Product Code: OCZ FDA class 2 21 CFR 876.1500

Endoscopic Grasping/Cutting Instrument, Non-Powered

Gastroenterology, Urology

The Non-Powered Endoscopic Grasping/Cutting Instrument for Gastroenterology-Urology (product code OCZ) is a manually operated device used through an endoscope to grasp stones, tissues, or foreign objects, and to manipulate, sample, or cut tissues within the GI or GU tract during diagnostic or therapeutic procedures. These instruments include biopsy forceps, snares, and stone retrieval baskets. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OCZ
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 74 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252800	KARL STORZ Endoscopic Accessories for Urology	Jun 03, 2026	Substantially Equivalent	Karl Storz SE & CO. KG
K242923	SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)	Dec 20, 2024	Substantially Equivalent	Envision Endoscopy
K191900	Single Use Grasping Forceps	Mar 27, 2020	Substantially Equivalent	Zhejiang Chuangxiang Medical Technology Co., Ltd.
K152802	Grasping Forceps	Jan 21, 2016	Substantially Equivalent	Micro-Tech (Nanjing) Co., Ltd.
K150939	Ensizor Endoscopic Scissors	Jun 08, 2015	Substantially Equivalent	Slater Endoscopy, LLC
K141058	ENSIZOR ENDOSCOPIC SCISSORS	Aug 01, 2014	Substantially Equivalent	Slater Endoscopy, LLC
K133736	ENDOSCOPIC SUTURE CUTTER	Jan 07, 2014	Substantially Equivalent	United States Endoscopy Group, Inc.
K120084	ENDOSCOPIC RETRIEVAL DEVICE	May 30, 2012	Substantially Equivalent	United States Endoscopy Group, Inc.
K103688	G-PROX EZ ENDOSCOPIC GRASPER	Jan 14, 2011	Substantially Equivalent	Usgi Medical
K101298	ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS	Aug 05, 2010	Substantially Equivalent	Endochoice, Inc.
K072684	MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM	Jan 04, 2008	Substantially Equivalent	Mondeal North America, Inc.
K051276	HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM	Oct 28, 2005	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K012074	XBO1-824-18/19/20 BIOPSY FORCEPS	Sep 25, 2001	Substantially Equivalent	The Olympus Optical Co.
K010412	FLEXIBLE ENDOSCOPIC SCISSORS	Apr 02, 2001	Substantially Equivalent	Telemed Systems, Inc.
K974300	TELEMED SYSTEMS RETRIEVAL BASKET	Dec 19, 1997	Substantially Equivalent	Telemed Systems, Inc.
K973071	TRI TALON RETRIEVAL FORCEPS	Oct 24, 1997	Substantially Equivalent	Medical Engineering Laboratory, Inc.
K973259	K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)	Sep 10, 1997	Substantially Equivalent	Medical Creative Technologies, Inc.
K971123	STONE EXTRACTOR	Jun 27, 1997	Substantially Equivalent	Phx Technologies Corp.
K971202	COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS	May 27, 1997	Substantially Equivalent	Comeg Endoskopie GmbH
K970982	T-RX RETRIEVAL FORCEPS	May 09, 1997	Substantially Equivalent	Tri-Med Specialties, Inc.
K965176	PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS	Mar 04, 1997	Substantially Equivalent	Pilling Weck Group
K961611	OLYMPUS BASKET GRASPERS (UROLOGY)	Jul 18, 1996	Substantially Equivalent	Olympus America, Inc.
K955066	OLYMPUS FG SERIES GRASPING FORCEPS	Jan 25, 1996	Substantially Equivalent	Olympus America, Inc.
K955063	OLYMPUS BASKET GRASPERS	Jan 22, 1996	Substantially Equivalent	Olympus America, Inc.
K955051	OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS	Jan 18, 1996	Substantially Equivalent	Olympus America, Inc.
K954536	BLADE, SCALPEL & BLADE, HANDEL	Nov 29, 1995	Substantially Equivalent	Access Surgical Intl., Inc.
K950434	KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES	Mar 29, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K943476	GIP/MEDI-GLOBE GOREIGN BODY GRASPERS	Dec 15, 1994	Substantially Equivalent	Medi-Globe Corp.
K941464	BASICS ENDOSCOPY SYSTEM	Aug 05, 1994	Substantially Equivalent	Cox Medical Ent., Inc.
K942030	BIOPSY SCISSORS	Jun 27, 1994	Substantially Equivalent	Surgical Technologies, Inc.
K930499	GRASPING FORCEPS FLEXIBLE STONE DISLODGER	Aug 16, 1993	Substantially Equivalent	Endomedix
K923489	COX DISPOSABLE RETRIEVAL DEVICES	Sep 23, 1992	Substantially Equivalent	Cox Medical Ent., Inc.
K920762	BIOSPSY FORCEPS	Aug 26, 1992	Substantially Equivalent	Symbiosis Corp.
K914503	GRASPING FORCEPS	Dec 05, 1991	Substantially Equivalent	Surgitek Medical Engineering Corp.
K902949	CORPAK GRASPING FORCEPS	Aug 30, 1990	Substantially Equivalent	Corpak Co.
K902400	WILSON-COOK RETRIEVAL & GRASPING FORCEPS	Aug 07, 1990	Substantially Equivalent	Wilson-Cook Medical, Inc.
K896502	PORGES BIOPSY & FOREIGN BODY FORCEPS	Jan 22, 1990	Substantially Equivalent	Porges Corp.
K894862	WILTEK GRASPING FORCEPS	Dec 21, 1989	Substantially Equivalent	Wiltek Medical, Inc.
K894986	3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET	Dec 01, 1989	Substantially Equivalent	North American Sterilization & Packaging Co.
K881332	DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH	Apr 27, 1988	Substantially Equivalent	Baxter Healthcare Corp
K881399	3 FRENCH FLEXIBLE BIOPSY FORCEPS	Apr 11, 1988	Substantially Equivalent	Cook Urological, Inc.
K873248	GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS	Dec 30, 1987	Substantially Equivalent	Medical Engineering Laboratory, Inc.
K874016	OVAL CUP BIOPSY FORCEP(23/5) USED W/GASTRO/SIGOIDO	Dec 29, 1987	Substantially Equivalent	Endovations
K874015	HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 23/12)	Dec 29, 1987	Substantially Equivalent	Endovations
K874014	OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)	Dec 29, 1987	Substantially Equivalent	Endovations
K874013	OVAL CUP BIOPSY FORCEP(23/5) USED W/COLONOSCOPE	Dec 29, 1987	Substantially Equivalent	Endovations
K874012	OVAL CUP BIOPSY FORCEP (MODEL 18/5)	Dec 29, 1987	Substantially Equivalent	Endovations
K874011	OVAL CUP WITH NEEDLE BIOPSY FORCEP (MODEL 23/1)	Dec 29, 1987	Substantially Equivalent	Endovations
K874010	ROUND CUP HOT BIOPSY FORCEP (MODEL D-52)	Dec 29, 1987	Substantially Equivalent	Endovations
K874009	OVAL CUP HOT BIOPSY FORCEP (MODEL C-52)	Dec 29, 1987	Substantially Equivalent	Endovations
K874008	OVAL CUP HOT BIOPSY FORCEP (MODEL B-51)	Dec 29, 1987	Substantially Equivalent	Endovations
K874007	OVAL CUP HOT BIOPSY FORCEP (MODEL A-51)	Dec 29, 1987	Substantially Equivalent	Endovations
K874006	GRASPING TRIPOD FORCEP (MODEL 23/25)	Dec 29, 1987	Substantially Equivalent	Endovations
K874005	RAT TOOTH GRASPING FORCEP (MODEL 23/20)	Dec 29, 1987	Substantially Equivalent	Endovations
K874004	ALLIGATOR JAW GRASPING FORCEP (MODEL 23/125)	Dec 29, 1987	Substantially Equivalent	Endovations
K874003	HOLLOW ALLIGATOR GRASPING FORCEP (MODEL 18/12)	Dec 29, 1987	Substantially Equivalent	Endovations
K871809	FLEXIBLE BIOPSY FORCEP	Jun 18, 1987	Substantially Equivalent	Surgi-Aid Endoscopics, Inc.
K870355	(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE	Apr 01, 1987	Substantially Equivalent	Cook Urological, Inc.
K865087	VAN-TEC DOUBLE SHEATH GRASPING FORCEPS	Mar 25, 1987	Substantially Equivalent	Van-Tec, Inc.
K845017	DAVOL RETRIEVAL BASKETS & FORCEPS	Jan 15, 1985	Substantially Equivalent	C.R. Bard, Inc.
K844074	HOBBS MEDICAL POLYPECTOMY SNARE	Jan 03, 1985	Substantially Equivalent	Hobbs Medical, Inc.
K840800	POLYP-SAVER SLEVE	Mar 23, 1984	Substantially Equivalent	Jayco Pharmaceuticals
K833124	HOBBS MEDICAL RETRIEVAL BASKET	Nov 29, 1983	Substantially Equivalent	Hobbs Medical, Inc.
K833125	HOBBS MEDICAL GRASPING FORCEPS	Oct 31, 1983	Substantially Equivalent	Hobbs Medical, Inc.
K830802	LOOP RETRIEVER	Apr 28, 1983	Substantially Equivalent	Van-Tec, Inc.
K820429	SPIRAL STONE AND RETRIEVAL BASKETS	Apr 08, 1982	Substantially Equivalent	American Endoscopy, Inc.
K800976	M.R. ASSOC. W TYPE GRASPING FORCEPS	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800972	M.R. ASSOC. TRIPOD GRASPING FORCEPS	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800970	M.R. ASSOC. BASKET RETRIEVERS	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800969	M.R. ASSOC. CANNULAS	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800968	M.R. ASSOC. RAT TOOTH GRASP FORCEPS	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K800967	M.R. ASSOC. ALLIGATOR GRASPONG FORCEPS	May 08, 1980	Substantially Equivalent	Mr Associates, Inc.
K792345	RETRIEVABLE FORCEPS	Dec 20, 1979	Substantially Equivalent	Mill-Rose Laboratory
K760180	FORCEPS, GRASPING	Dec 02, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.