Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Ethicon Endo-Surgery, Inc. — Predicate Candidate Screening

112 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

83 daysmedian FDA review time

191 days90th percentile

112clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141952	ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMEN	Ethicon Endo-Surgery, Inc.	2014-11-24	129	2
K111195	VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS	Ethicon Endo-Surgery, Inc.	2011-08-03	97	0
K110385	ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR	Ethicon Endo-Surgery, Inc.	2011-03-25	43	0
K101520	ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL51	Ethicon Endo-Surgery, Inc.	2010-12-10	191	0
K102632	ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER	Ethicon Endo-Surgery, Inc.	2010-10-07	24	0
K093896	ETHICON ENDO SURGERY SLOTTED ANOSCOPE	Ethicon Endo-Surgery, Inc.	2010-03-25	97	0
K091259	ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS	Ethicon Endo-Surgery, Inc.	2010-01-15	261	0
K091824	ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2	Ethicon Endo-Surgery, Inc.	2009-11-27	161	0
K093236	ETHICON ENDO-SURGERYOPTICAL DILATOR	Ethicon Endo-Surgery, Inc.	2009-11-10	26	0
K091290	ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508	Ethicon Endo-Surgery, Inc.	2009-10-29	181	0
K091322	CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS	Ethicon Endo-Surgery, Inc.	2009-06-01	27	0
K082955	ETHICON ENDO-SURGERY ARTICULATING HOOK KNIFE, MODEL IN4505	Ethicon Endo-Surgery, Inc.	2009-01-15	104	0
K073288	ETHICON ENDO SURGERY ARTICULATING SNARE	Ethicon Endo-Surgery, Inc.	2008-06-12	204	0
K073484	ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANN	Ethicon Endo-Surgery, Inc.	2008-03-10	90	0
K073046	ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504	Ethicon Endo-Surgery, Inc.	2008-02-25	119	0
K061770	ETHICON ENDO SURGERY ENDOSCOPIC SUTURING SYSTEM	Ethicon Endo-Surgery, Inc.	2006-09-25	94	0
K062000	HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAN	Ethicon Endo-Surgery, Inc.	2006-09-25	70	0
K061156	ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60	Ethicon Endo-Surgery, Inc.	2006-07-03	68	2
K060245	HARMONIC SCALPEL BLADES AND SHEARS	Ethicon Endo-Surgery, Inc.	2006-04-07	66	0
K053631	CONTOUR TRANSTAR CURVED CUTTER STAPLER SET	Ethicon Endo-Surgery, Inc.	2006-01-30	32	0
K053056	HARMONIC SCALPEL BLADES AND SHEARS	Ethicon Endo-Surgery, Inc.	2006-01-19	80	0
K051950	INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321	Ethicon Endo-Surgery, Inc.	2005-10-07	81	0
K051301	PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES	Ethicon Endo-Surgery, Inc.	2005-08-30	103	2
K051036	HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTR	Ethicon Endo-Surgery, Inc.	2005-06-02	38	0
K051002	ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER	Ethicon Endo-Surgery, Inc.	2005-05-17	27	1
K050344	LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER	Ethicon Endo Surgery, Inc.	2005-03-14	31	0
K042777	HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P,	Ethicon Endo-Surgery, Inc.	2004-12-01	56	0
K042897	AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE	Ethicon Endo-Surgery, Inc.	2004-11-19	30	0
K042753	MAMMOTOME MR BIOPSY SYSTEM	Ethicon Endo-Surgery, Inc.	2004-11-08	35	0
K033700	MAMMOTOME EX HAND HELD SYSTEM	Ethicon Endo-Surgery, Inc.	2004-02-20	87	1
K040038	CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVE	Ethicon Endo-Surgery, Inc.	2004-02-04	27	0
K031147	OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR	Ethicon Endo-Surgery, Inc.	2004-01-12	277	0
K033269	ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRID	Ethicon Endo-Surgery, Inc.	2003-12-10	62	0
K032676	ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPA	Ethicon Endo-Surgery, Inc.	2003-10-30	62	0
K030472	MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD	Ethicon Endo-Surgery, Inc.	2003-10-09	239	0
K030925	PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES,	Ethicon Endo-Surgery, Inc.	2003-05-15	52	1
K030571	ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV C	Ethicon Endo-Surgery, Inc.	2003-03-28	32	0
K030411	PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES,	Ethicon Endo-Surgery, Inc.	2003-03-20	41	1
K023182	INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-B	Ethicon Endo-Surgery, Inc.	2002-10-24	30	0
K021266	ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW01	Ethicon Endo-Surgery, Inc.	2002-09-27	158	0
K020779	PROXIMATE AND ENDOPATH LINEAR CUTTERS AND STAPLERS	Ethicon Endo-Surgery, Inc.	2002-06-05	86	17
K020276	8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535	Ethicon Endo-Surgery, Inc.	2002-04-12	74	0
K020428	ENDOPATH DILATING TIP TROCAR, MODEL #512XD	Ethicon Endo-Surgery, Inc.	2002-03-04	24	0
K013749	ENDOANCHOR AND OPENANCHOR	Ethicon Endo-Surgery, Inc.	2002-02-11	90	0
K013576	PERICSCOPE, MODEL # PERISC1	Ethicon Endo-Surgery, Inc.	2002-01-25	88	0
K013493	INDIGO OPTIMA LASER SYSTEM	Ethicon Endo-Surgery, Inc.	2001-12-13	52	0
K013413	MICROMARK II TISSUE MARKER,MODEL C1535	Ethicon Endo-Surgery, Inc.	2001-12-03	49	0
K012176	ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE,	Ethicon Endo-Surgery, Inc.	2001-10-01	81	0
K011538	ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM	Ethicon Endo-Surgery, Inc.	2001-08-09	83	0
K012128	PROTECTIV ACUVANCE IV CATHETER SYSTEM	Ethicon Endo-Surgery, Inc.	2001-08-01	23	1

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda