Ethicon Endo-Surgery, Inc.
Ethicon Endo-Surgery, Inc. holds FDA 510(k) medical device clearances, first cleared 1992, most recent 2014, with 54 FDA device recalls on record.
Name variants for Ethicon Endo-Surgery, Inc.
as filed with FDA- Ethicon Endo-Surgery, Inc.
- Ethicon Endo Surgery, Inc.
Top product codes for Ethicon Endo-Surgery, Inc.
FDA recalls by Ethicon Endo-Surgery, Inc.
10 most recent of 54- Z-0147-2026 — ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
- Z-1746-2025 — Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
- Z-0834-2024 — ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
- Z-2355-2021 — HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
- Z-2356-2021 — HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
- Z-2326-2021 — ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. Product Code: PSEE60A
- Z-0656-2020 — Ligamax 5 mm Endoscopic Multiple Clip Applier
- Z-0200-2020 — ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
- Z-0202-2020 — ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
- Z-0203-2020 — ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
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 Ethicon Endo-Surgery, Inc.
1–100 of 112- K141952 — ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
- K111195 — VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
- K110385 — ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
- K101520 — ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
- K102632 — ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
- K093896 — ETHICON ENDO SURGERY SLOTTED ANOSCOPE
- K091259 — ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
- K091824 — ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
- K093236 — ETHICON ENDO-SURGERYOPTICAL DILATOR
- K091290 — ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
- K091322 — CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G
- K082955 — ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505
- K073288 — ETHICON ENDO SURGERY ARTICULATING SNARE
- K073484 — ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431; COLONOSCOPE, MODEL IN0432
- K073046 — ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504
- K061770 — ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM
- K062000 — HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH
- K061156 — ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS
- K060245 — HARMONIC SCALPEL BLADES AND SHEARS
- K053631 — CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
- K053056 — HARMONIC SCALPEL BLADES AND SHEARS
- K051950 — INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
- K051301 — PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
- K051036 — HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P
- K051002 — ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
- K050344 — LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
- K042777 — HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P
- K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
- K042753 — MAMMOTOME MR BIOPSY SYSTEM
- K033700 — MAMMOTOME EX HAND HELD SYSTEM
- K040038 — CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G
- K031147 — OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
- K033269 — ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
- K032676 — ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR
- K030472 — MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
- K030925 — PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH01
- K030571 — ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER
- K030411 — PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03
- K023182 — INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
- K021266 — ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018
- K020779 — PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS
- K020276 — 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535
- K020428 — ENDOPATH DILATING TIP TROCAR, MODEL #512XD
- K013749 — ENDOANCHOR AND OPENANCHOR
- K013576 — PERICSCOPE, MODEL # PERISC1
- K013493 — INDIGO OPTIMA LASER SYSTEM
- K013413 — MICROMARK II TISSUE MARKER,MODEL C1535
- K012176 — ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
- K011538 — ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM
- K012128 — PROTECTIV ACUVANCE IV CATHETER SYSTEM
- K011501 — ENDOPOUCH RETRIEVER
- K011257 — ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
- K010870 — LAP DISC 120 X 120, MODEL LD111, LAP DISC 120 X 100, MODEL LD112, LAP DISC 70 X 70, MODEL LD113
- K010898 — ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
- K002981 — ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150
- K003952 — INDIGO LASEROPTIC TREATMENT SYSTEM
- K003953 — INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
- K003297 — MAMMOTOME HAND HELD PROBE, MODEL MHH8
- K002906 — ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
- K002398 — ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
- K001220 — ENDOPATH SURESEAL REDUCER CAP
- K994280 — ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
- K993054 — ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141
- K992813 — 11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT
- K992612 — ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM WITH COATED VICRYL, MODELS SW210, SW220, SW220,SW230, SW212, SW222 AND SW232
- K990362 — INSTRUMENT, ULTRASONIC, SCALPEL
- K991980 — MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,
- K984240 — ENDOPATH ENDOSCOPIC INSTRUMENTS
- K991030 — PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
- K990028 — ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
- K990430 — ULTRACISION HARMONIC SCALPEL HAND PIECE
- K983925 — ENDOPATH ULTRA VERESS NEEDLE
- K983536 — PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
- K983316 — ULTRACISION 5MM INSTRUMENTS
- K980815 — ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
- K980099 — ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))
- K980023 — ENDOPATH AND PROXIMATE LINEAR CUTTERS
- K980022 — ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
- K973803 — FLEXVIEW CO2 BLOWER WITH MIST
- K973139 — ENDOPATH ULTRA-RETRACTOR/ ENDOPATH VESSEL DISSECTOR
- K972578 — ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE
- K972679 — ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS)
- K971475 — SHIELDED SURGICAL TROCAR
- K971738 — ENDOPATH RESPOSABLE TROCAR SYSTEM
- K971302 — ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE
- K970720 — ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER AND THE ENDOPATH EZ45 NO KNIFE ENDOSCOPIC LINEAR STAPLER
- K965045 — TRISTAR LP TORCAR WITH LOW PROFILE THREADED SLEEVE
- K970079 — PROXIMATE DISPOSABLE SKIN STAPLER
- K963760 — NON-SHIELDED SURGICAL TROCAR AND SLEEVE
- K962584 — ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
- K962258 — ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
- K961264 — ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION
- K961390 — ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
- K955120 — HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR
- K954089 — ENDOPATH OPEN OR ENDOSCOPIC ELECTROSUGICAL COAGULATION & CUTTING DEVICE
- K952842 — ENDOPATH* TRISTAR FLAT BLADED SURGICAL OBTURATOR & SLEEVE
- K951546 — ENDOPATH AND PROXIMATE LINEAR CUTTERS AND STAPLERS
- K951444 — ENDOPATH OPTICAL ACCESS NEEDKLE
- K946241 — ENDOPATH(R) TRISTAR(TM) DISSECTOR AND TISSUE MANIPULATOR
- K945202 — ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER WITH SAFETY LOC-OUT AND RELOADING UNIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.