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

OCZ · Predicate Candidate Screening

74 FDA 510(k) clearances under this product code; the 50 most recent screened below.

77 daysmedian FDA review time

143 days90th percentile

74clearances measured

K-number	Device	Applicant	Decided	Review days
K252800	KARL STORZ Endoscopic Accessories for Urology	Karl Storz SE & CO. KG	2026-06-03	273
K242923	SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip E	Envision Endoscopy	2024-12-20	87
K191900	Single Use Grasping Forceps	Zhejiang Chuangxiang Medical Technology Co., Ltd.	2020-03-27	255
K152802	Grasping Forceps	Micro-Tech (Nanjing) Co., Ltd.	2016-01-21	115
K150939	Ensizor Endoscopic Scissors	Slater Endoscopy, LLC	2015-06-08	62
K141058	ENSIZOR ENDOSCOPIC SCISSORS	Slater Endoscopy, LLC	2014-08-01	99
K133736	ENDOSCOPIC SUTURE CUTTER	United States Endoscopy Group, Inc.	2014-01-07	29
K120084	ENDOSCOPIC RETRIEVAL DEVICE	United States Endoscopy Group, Inc.	2012-05-30	140
K103688	G-PROX EZ ENDOSCOPIC GRASPER	Usgi Medical	2011-01-14	28
K101298	ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL	Endochoice, Inc.	2010-08-05	87
K072684	MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM	Mondeal North America, Inc.	2008-01-04	105
K051276	HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM	Richard Wolf Medical Instruments Corp.	2005-10-28	164
K012074	XBO1-824-18/19/20 BIOPSY FORCEPS	The Olympus Optical Co.	2001-09-25	85
K010412	FLEXIBLE ENDOSCOPIC SCISSORS	Telemed Systems, Inc.	2001-04-02	49
K974300	TELEMED SYSTEMS RETRIEVAL BASKET	Telemed Systems, Inc.	1997-12-19	32
K973071	TRI TALON RETRIEVAL FORCEPS	Medical Engineering Laboratory, Inc.	1997-10-24	67
K973259	K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)	Medical Creative Technologies, Inc.	1997-09-10	12
K971123	STONE EXTRACTOR	Phx Technologies Corp.	1997-06-27	92
K971202	COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATOR	Comeg Endoskopie GmbH	1997-05-27	56
K970982	T-RX RETRIEVAL FORCEPS	Tri-Med Specialties, Inc.	1997-05-09	52
K965176	PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS	Pilling Weck Group	1997-03-04	70
K961611	OLYMPUS BASKET GRASPERS (UROLOGY)	Olympus America, Inc.	1996-07-18	84
K955066	OLYMPUS FG SERIES GRASPING FORCEPS	Olympus America, Inc.	1996-01-25	80
K955063	OLYMPUS BASKET GRASPERS	Olympus America, Inc.	1996-01-22	77
K955051	OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS	Olympus America, Inc.	1996-01-18	73
K954536	BLADE, SCALPEL & BLADE, HANDEL	Access Surgical Intl., Inc.	1995-11-29	61
K950434	KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS,	KARL STORZ Endoscopy-America, Inc.	1995-03-29	55
K943476	GIP/MEDI-GLOBE GOREIGN BODY GRASPERS	Medi-Globe Corp.	1994-12-15	149
K941464	BASICS ENDOSCOPY SYSTEM	Cox Medical Ent., Inc.	1994-08-05	130
K942030	BIOPSY SCISSORS	Surgical Technologies, Inc.	1994-06-27	62
K930499	GRASPING FORCEPS FLEXIBLE STONE DISLODGER	Endomedix	1993-08-16	196
K923489	COX DISPOSABLE RETRIEVAL DEVICES	Cox Medical Ent., Inc.	1992-09-23	70
K920762	BIOSPSY FORCEPS	Symbiosis Corp.	1992-08-26	189
K914503	GRASPING FORCEPS	Surgitek Medical Engineering Corp.	1991-12-05	57
K902949	CORPAK GRASPING FORCEPS	Corpak Co.	1990-08-30	56
K902400	WILSON-COOK RETRIEVAL & GRASPING FORCEPS	Wilson-Cook Medical, Inc.	1990-08-07	69
K896502	PORGES BIOPSY & FOREIGN BODY FORCEPS	Porges Corp.	1990-01-22	68
K894862	WILTEK GRASPING FORCEPS	Wiltek Medical, Inc.	1989-12-21	143
K894986	3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET	North American Sterilization & Packaging Co.	1989-12-01	115
K881332	DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH	Baxter Healthcare Corp	1988-04-27	29
K881399	3 FRENCH FLEXIBLE BIOPSY FORCEPS	Cook Urological, Inc.	1988-04-11	7
K873248	GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS	Medical Engineering Laboratory, Inc.	1987-12-30	138
K874016	OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDO	Endovations	1987-12-29	89
K874012	OVAL CUP BIOPSY FORCEP (MODEL 18/5)	Endovations	1987-12-29	89
K874006	GRASPING TRIPOD FORCEP (MODEL 23/25)	Endovations	1987-12-29	89
K874004	ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125)	Endovations	1987-12-29	89
K874003	HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)	Endovations	1987-12-29	89
K874005	RAT TOOTH GRASPING FORCEP (MODEL 23/20)	Endovations	1987-12-29	89
K874009	OVAL CUP HOT BIOPSY FORCEP (MODEL C-52)	Endovations	1987-12-29	89
K874010	ROUND CUP HOT BIOPSY FORCEP (MODEL D-52)	Endovations	1987-12-29	89

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