HIH
Endosee System
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 169
Adverse events under product code HIH
product code HIH- Death
- 18
- Injury
- 973
- Malfunction
- 5,071
- Other
- 1
- Total
- 6,063
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HIH
1–100 of 169- K254251 — InnovexView (GC146-17, GC150-20, GC155-23)
- K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)
- K252012 — SPY Cystoscope/Hysteroscope
- K243382 — RZ Resectoscope System
- K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
- K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
- K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
- K231260 — HTx Disposable Hysteroscope System
- K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope
- K233635 — SPY Cystoscope/Hysteroscope
- K233500 — Benesta Tissue Removal Device
- K223885 — HOPKINS Telescopes
- K223813 — Aveta System 2.0
- K223520 — UNIDRIVE SIII System
- K221557 — Visera Hysterovideoscope Olympus HYF Type V
- K213171 — Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
- K213207 — Sheath, Stopcock Accessory
- K202445 — Hystero-V Hysteroscope
- K210270 — Medical Endoscope Image Processing System
- K211227 — HTx Disposable Hysteroscope System
- K192811 — BenestaTM Tissue Removal Device
- K201970 — Schoelly Cystoscopes/Hysteroscopes and Accessories
- K201756 — Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent
- K192822 — Benesta Hysteroscope
- K200038 — Endosee System
- K193007 — LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
- K191538 — Resectr Tissue Resection Device
- K192100 — Aveta Disposable Hysteroscope
- K190797 — Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)
- K192278 — Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)
- K191958 — Aveta System
- K191281 — Omni Hysteroscope, Omni Lok cervical seal
- K190827 — Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid
- K191335 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- K182975 — MAKO 7
- K190372 — Aveta System
- K190639 — Endosee System
- K181545 — Hysteroscope System
- K190113 — Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
- K183020 — Endosee System
- K182675 — Polygon Resection Device
- K182006 — Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths
- K180496 — TruClear Elite Hysteroscope
- K181974 — MyoSure XL Tissue Removal Device for Fluent
- K180752 — Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
- K173070 — HSW Resection Instruments
- K173901 — MyoSure MANUAL Tissue Removal Device
- K180096 — GDT-1000 System
- K171113 — LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
- K172566 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
- K170660 — Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula
- K161763 — Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device
- K160751 — Symphion Endoscope and Symphion Cervical Sheath
- K160510 — MAKO 7
- K151275 — MAKO Device
- K152723 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
- K152143 — TRUCLEAR Operative Hysteroscope 5C and Sheath 5C
- K150158 — Schoelly Cystoscopes/Hysteroscopes and Accessories
- K141515 — AED HYSTEROSCOPE AND ACCESSORIES
- K142029 — MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
- K132384 — U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
- K132015 — TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
- K131581 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
- K131736 — MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK)
- K123330 — IOGYN ENDOSCOPE
- K123151 — ENDOSEE MODEL 8000 U-SCOPE
- K122563 — MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL
- K122498 — MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
- K121868 — MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
- K120593 — MYOSURE CONTROL UNIT
- K112134 — TRUCLEAR OPERATIVE HYSTEROSCOPE
- K110038 — TRUCLEAR MORCELLATOR SYSTEM
- K103389 — TRUCLEAR INCISOR PLUS BLADE 2.9
- K102686 — MYOSURE ROD LENS SCOPE SEALS
- K093218 — FEMEYE TWO
- K100559 — MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
- K092421 — ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
- K091838 — OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
- K091100 — MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
- K092278 — GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
- K091465 — MYOSURE ROD LENS HYSTEROSCOPE
- K081070 — INTERLACE MEDICAL OPERATIVE HYSTEROSCOPY SYSTEM
- K073690 — INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
- K071127 — FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM
- K053583 — OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL
- K041774 — IUR RECIPROCATING MORCELLATOR MODEL # 7210517
- K040390 — STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
- K040302 — VERSAPOINT RESECTOSCOPIC SYSTEM
- K033113 — UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753
- K031787 — SMITH & NEPHEW IUR MORCELLATION SYSTEM
- K031974 — ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
- K022445 — VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
- K022480 — ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC
- K012869 — GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
- K013870 — SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224
- K003802 — HYSTEROSCOPES
- K001740 — KSEA MONOPOLAR VAPORIZATION ELECTRODES
- K000673 — HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
- K994418 — VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
- K992901 — GYNECARE VERSAPOINT G-VAP ELECTRODE
Data sourced from openFDA. This site is unofficial and independent of the FDA.