Stryker Endoscopy
Stryker Endoscopy holds FDA 510(k) medical device clearances, first cleared 1993, most recent 2026, with 238 FDA device recalls on record.
Top product codes for Stryker Endoscopy
FDA recalls by Stryker Endoscopy
10 most recent of 238- Z-1566-2016 — PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High Flow Insufflator is a device that serves to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy. The insufflator consists of a console, that is intended to be connected to a CO2 gas source, and has a tubeset inserted to transport CO2 gas from the insufflator to the connecting trocar.
- Z-1831-2015 — SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the hemostasis of blood vessels.
- Z-0595-2015 — PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
- Z-0667-2015 — PKG, BIPOLAR FORCEPS, FENESTRATED 45CM, P/N 0250080113. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
- Z-0782-2015 — PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
- Z-0662-2015 — PKG, TROCAR, 8MM, PYRAMIDAL TIP, P/N 0250080155. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
- Z-0741-2015 — PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
- Z-0653-2015 — PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
- Z-0600-2015 — PKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
- Z-0787-2015 — PKG, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Stryker Endoscopy
1–100 of 103- K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down
- DEN250040 — SportSuite Vision Software
- K253602 — Precision S 4K Sinuscope
- K261037 — 780 nm SPY Portable Handheld Imaging (SPY-PHI) System
- K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality
- K260108 — L12 LED Light Source with AIM
- K254014 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K253888 — MOLLI 2 System
- K252010 — SPY Laparoscope
- K252012 — SPY Cystoscope/Hysteroscope
- K250544 — Knotilus+ Biocomposite Knotless Anchor
- K250528 — Stryker AlphaVent Knotless SP Biocomposite Anchor
- K241401 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K240407 — ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor
- K240174 — 1688 4K Camera System with Advanced Imaging Modality
- K233635 — SPY Cystoscope/Hysteroscope
- K233893 — AlphaVent Knotless SP PEEK Anchor
- K233327 — 1788 4K Camera System with Advanced Imaging Modality
- K232683 — Knotilus+ PEEK Knotless Anchor
- K231093 — AlphaVent Suture Anchors
- K230886 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K222079 — Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- K220108 — SDC4K Information Management System with Device and Voice Control Package
- K211502 — Alpha Vent PEEK Suture Anchor
- K210078 — Stryker ProCinch Adjustable Loop Device
- K160332 — Stryker SDC3 HD Information Management System with Wireless Device Control Capability
- K151243 — STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
- K150416 — ProCinch Adjustable Loop Device
- K150127 — Laparoscopic Handles with peek Insulation
- K142310 — Stryker Infrared Fluorescence (IRF) Imaging System
- K142603 — Stryker Precision HD Camera System
- K132785 — STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY
- K130826 — PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER
- K123441 — STRYKER CROSSFLOW ARTHROSCOPY PUMP
- K121112 — STRYKER VIDEO URETEROSCOPE
- K121893 — STRYKER SDC3 HD INFORMATION MANAGEMENT SYSTEM
- K093677 — STRYKER ARTHROSCOPE
- K082451 — STRYKER VIDEOSCOPE
- K081995 — STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)
- K071859 — STRYKER CROSSFIRE SYSTEM
- K071157 — STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
- K070882 — STRYKER PEEK TWINLOOP TAC
- K070758 — STRYKER PEEK ZIP SUTURE ANCHOR
- K060085 — STRYKER SCOPE/INSTRUMENT HOLDER
- K053311 — STRYKER SCOPE WARMER
- K052141 — STRYKER STILETTO ELECTROSURGICAL PROBE
- K043021 — STRYKER URETEROSCOPE
- K043022 — STRYKER FLEXIBLE CYSTONEPHROSCOPE
- K041810 — SERFAS ENERGY SYSTEM
- K042454 — STRYKER CASSETTE PUMP
- K033135 — STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
- K041305 — STRYKER BIOZIP SUTURE ANCHOR SYSTEM
- K041307 — MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
- K041310 — STRYKER WEDGE SUTURE ANCHOR SYSTEM
- K040390 — STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
- K032901 — STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
- K033252 — MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
- K031278 — STRYKER FLEXIBLE URETEROSCOPE
- K031068 — STRYKER VISUM SURGICAL LIGHTING SYSTEM
- K022393 — MERDOC SYSTEM
- K023192 — STRYKER BIOZIP SUTURE ANCHOR
- K024159 — STRYKERWARE SYSTEM
- K023013 — STRYKER XCEL ANCHOR SYSTEM
- K022248 — STRYKER L3 HYDROLERT
- K020097 — STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
- K012270 — STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
- K011319 — STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
- K993166 — STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
- K000493 — STRYKER IRRIGATION TUBE SET
- K993045 — BARIATRIC LAPAROSCOPE, MODEL 367
- K991960 — SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH
- K983220 — STRYKER INFRAVISION ESOPHAGEAL KIT
- K990038 — HUMMER TRAK SYSTEM
- K983566 — 3-CHIP VIDEO CAMERA
- K983557 — STRYKER WEDGE SUTURE ANCHOR
- K982375 — STRYKER HIP ARTHOROSCOPY SET
- K982542 — STRYKER URETERAL ILLUMINATOR SYSTEM III
- K974771 — STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
- K973195 — TOTAL PERFORMANCE SYSTEM SHAVER
- K972584 — STRYKER HUMMER II MICRODEBRIDER SYSTEM
- K972233 — STRYKER WEDGE INTERFERENCE SCREW SYSTEM
- K963646 — STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW
- K964930 — STRYKER SAPHENOUS VEIN HARVEST SCOPE
- K963765 — STRYKER STRYKEFLOW ELECTROCAUTERY PROBES
- K963304 — STRYKER TEMPEST ORTHOPEDIC PUMP
- K963648 — STRYKER SUCTION REGULATOR
- K963332 — THERMO-PLASTIC SHAVER BLADES
- K961971 — Q-5000
- K954726 — STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
- K952460 — STRYKER ACL INTERFERENCE SCREW SYSTEM
- K944593 — STRYKER PRESSURE SENSING CANNULA
- K951267 — STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM
- K943100 — STRYKER OPERATING LAPAROSCOPE
- K952681 — STRYKER HUMMER II MICRODEBRIDER SYSTEM
- K944210 — ARTHROSCOPE ACCESSORIES
- K943508 — INSUFFLATOR TUBING WITH FILTER
- K941333 — SE5 ARTHROSCOPY SYTEM
- K944186 — SINUSCOPE
- K935221 — STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS
- K935222 — STRYKER ENDOSCOPIC ELECTROSURGICAL INSTRUMENTS & ACCESORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.