Endoscopic Grasping/Cutting Instrument, Non-Powered
FDA product code OCZ · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
74510(k) clearances
0PMA approvals
21recalls
Manufacturers
- Endovations 14
- Mr Associates, Inc. 6
- Olympus America, Inc. 4
- Hobbs Medical, Inc. 3
- Cox Medical Ent., Inc. 2
- Telemed Systems, Inc. 2
- United States Endoscopy Group, Inc. 2
- Medical Engineering Laboratory, Inc. 2
- Cook Urological, Inc. 2
- Slater Endoscopy, LLC 2
- Van-Tec, Inc. 2
- Surgi-Aid Endoscopics, Inc. 1
- Jayco Pharmaceuticals 1
- Baxter Healthcare Corp 1
- North American Sterilization & Packaging Co. 1
- Wiltek Medical, Inc. 1
- Porges Corp. 1
- Corpak Co. 1
- American Endoscopy, Inc. 1
- Mill-Rose Laboratory 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252800 | KARL STORZ Endoscopic Accessories for UrologyOCZ · Traditional | Karl Storz SE & CO. KG | 06/03/2026SE |
| K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…OCZ · Traditional | Envision Endoscopy | 12/20/2024SE |
| K191900 | Single Use Grasping ForcepsOCZ · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 03/27/2020SE |
| K152802 | Grasping ForcepsOCZ · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 01/21/2016SE |
| K150939 | Ensizor Endoscopic ScissorsOCZ · Traditional | Slater Endoscopy, LLC | 06/08/2015SE |
| K141058 | Ensizor Endoscopic ScissorsOCZ · Traditional | Slater Endoscopy, LLC | 08/01/2014SE |
| K133736 | Endoscopic Suture CutterOCZ · Traditional | United States Endoscopy Group, Inc. | 01/07/2014SE |
| K120084 | Endoscopic Retrieval DeviceOCZ · Traditional | United States Endoscopy Group, Inc. | 05/30/2012SE |
| K103688 | G-Prox Ez Endoscopic GrasperOCZ · Special | Usgi Medical | 01/14/2011SE |
| K101298 | Endochoice Grasping Insulated and Aligator Jaw Forceps Model Amhgfa, Endochoice Grasping…OCZ · Traditional | Endochoice, Inc. | 08/05/2010SE |
| K072684 | Mondeal Endoscopic Tissue Recession and Release SystemOCZ · Traditional | Mondeal North America, Inc. | 01/04/2008SE |
| K051276 | Hysafe Micro Modular Forceps and Scissors SystemOCZ · Traditional | Richard Wolf Medical Instruments Corp. | 10/28/2005SE |
| K012074 | XBO1-824-18/19/20 Biopsy ForcepsOCZ · Traditional | The Olympus Optical Co. | 09/25/2001SE |
| K010412 | Flexible Endoscopic ScissorsOCZ · Traditional | Telemed Systems, Inc. | 04/02/2001SE |
| K974300 | Telemed Systems Retrieval BasketOCZ · Traditional | Telemed Systems, Inc. | 12/19/1997SE |
| K973071 | Tri Talon Retrieval ForcepsOCZ · Traditional | Medical Engineering Laboratory, Inc. | 10/24/1997SE |
| K973259 | K&W 2-PIECE Take-Apart Instruments(Various)OCZ · Traditional | Medical Creative Technologies, Inc. | 09/10/1997SE |
| K971123 | Stone ExtractorOCZ · Traditional | Phx Technologies Corp. | 06/27/1997SE |
| K971202 | Comeg Optical Stone Crushing Forceps, Comeg Visual Obturators for Urology, Comeg Optical…OCZ · Traditional | Comeg Endoskopie GmbH | 05/27/1997SE |
| K970982 | T-Rx Retrieval ForcepsOCZ · Traditional | Tri-Med Specialties, Inc. | 05/09/1997SE |
| K965176 | Pilling Weck 2 Piece Take-Apart InstrumentsOCZ · Traditional | Pilling Weck Group | 03/04/1997SE |
| K961611 | Olympus Basket Graspers (Urology)OCZ · Traditional | Olympus America, Inc. | 07/18/1996SE |
| K955066 | Olympus FG Series Grasping ForcepsOCZ · Traditional | Olympus America, Inc. | 01/25/1996SE |
| K955063 | Olympus Basket GraspersOCZ · Traditional | Olympus America, Inc. | 01/22/1996SE |
| K955051 | Olympus FG Series of Rat Tooth Grasping ForcepsOCZ · Traditional | Olympus America, Inc. | 01/18/1996SE |
| K954536 | Blade, Scalpel & Blade, HandelOCZ · Traditional | Access Surgical Intl., Inc. | 11/29/1995SE |
| K950434 | Karl Storz Flexible Grasping, Biopsy Forceps, Stone Baskets, Dislodgers, Scissors…OCZ · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/29/1995SE |
| K943476 | Gip/Medi-Globe Goreign Body GraspersOCZ · Traditional | Medi-Globe Corp. | 12/15/1994SE |
| K941464 | Basics Endoscopy SystemOCZ · Traditional | Cox Medical Ent., Inc. | 08/05/1994SE |
| K942030 | Biopsy ScissorsOCZ · Traditional | Surgical Technologies, Inc. | 06/27/1994SE |
| K930499 | Grasping Forceps Flexible Stone DislodgerOCZ · Traditional | Endomedix | 08/16/1993SE |
| K923489 | Cox Disposable Retrieval DevicesOCZ · Traditional | Cox Medical Ent., Inc. | 09/23/1992SE |
| K920762 | Biospsy ForcepsOCZ · Traditional | Symbiosis Corp. | 08/26/1992SE |
| K914503 | Grasping ForcepsOCZ · Traditional | Surgitek Medical Engineering Corp. | 12/05/1991SE |
| K902949 | Corpak Grasping ForcepsOCZ · Traditional | Corpak Co. | 08/30/1990SE |
| K902400 | Wilson-Cook Retrieval & Grasping ForcepsOCZ · Traditional | Wilson-Cook Medical, Inc. | 08/07/1990SE |
| K896502 | Porges Biopsy & Foreign Body ForcepsOCZ · Traditional | Porges Corp. | 01/22/1990SE |
| K894862 | Wiltek Grasping ForcepsOCZ · Traditional | Wiltek Medical, Inc. | 12/21/1989SE |
| K894986 | 3-RING Handle, Grasp Forceps, Loop Retrie., BasketOCZ · Traditional | North American Sterilization & Packaging Co. | 12/01/1989SE |
| K881332 | Diaflex Grasp Forceps/Retrieval Loop & Cyto BrushOCZ · Traditional | Baxter Healthcare Corp | 04/27/1988SE |
| K881399 | 3 French Flexible Biopsy ForcepsOCZ · Traditional | Cook Urological, Inc. | 04/11/1988SE |
| K873248 | Gastrointestinal Flexible Biospy ForcepsOCZ · Traditional | Medical Engineering Laboratory, Inc. | 12/30/1987SE |
| K874016 | Oval Cup Biopsy FORCEP(23/5) Used W/Gastro/SigoidoOCZ · Traditional | Endovations | 12/29/1987SE |
| K874015 | Hollow Alligator Grasping Forcep (Model 23/12)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874014 | Oval Cup with Needle Biopsy Forcep (Model 23/1)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874013 | Oval Cup Biopsy FORCEP(23/5) Used W/ColonoscopeOCZ · Traditional | Endovations | 12/29/1987SE |
| K874012 | Oval Cup Biopsy Forcep (Model 18/5)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874011 | Oval Cup with Needle Biopsy Forcep (Model 23/1)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874010 | Round Cup Hot Biopsy Forcep (Model D-52)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874009 | Oval Cup Hot Biopsy Forcep (Model C-52)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874008 | Oval Cup Hot Biopsy Forcep (Model B-51)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874007 | Oval Cup Hot Biopsy Forcep (Model A-51)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874006 | Grasping Tripod Forcep (Model 23/25)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874005 | Rat Tooth Grasping Forcep (Model 23/20)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874004 | Alligator Jaw Grasping Forcep (Model 23/125)OCZ · Traditional | Endovations | 12/29/1987SE |
| K874003 | Hollow Alligator Grasping Forcep (Model 18/12)OCZ · Traditional | Endovations | 12/29/1987SE |
| K871809 | Flexible Biopsy ForcepOCZ · Traditional | Surgi-Aid Endoscopics, Inc. | 06/18/1987SE |
| K870355 | (Ureteroscopic) Stricture Scapel or KnifeOCZ · Traditional | Cook Urological, Inc. | 04/01/1987SE |
| K865087 | Van-Tec Double Sheath Grasping ForcepsOCZ · Traditional | Van-Tec, Inc. | 03/25/1987SE |
| K845017 | Davol Retrieval Baskets & ForcepsOCZ · Traditional | C.R. Bard, Inc. | 01/15/1985SE |
| K844074 | Hobbs Medical Polypectomy SnareOCZ · Traditional | Hobbs Medical, Inc. | 01/03/1985SE |
| K840800 | Polyp-Saver SleveOCZ · Traditional | Jayco Pharmaceuticals | 03/23/1984SE |
| K833124 | Hobbs Medical Retrieval BasketOCZ · Traditional | Hobbs Medical, Inc. | 11/29/1983SE |
| K833125 | Hobbs Medical Grasping ForcepsOCZ · Traditional | Hobbs Medical, Inc. | 10/31/1983SE |
| K830802 | Loop RetrieverOCZ · Traditional | Van-Tec, Inc. | 04/28/1983SE |
| K820429 | Spiral Stone and Retrieval BasketsOCZ · Traditional | American Endoscopy, Inc. | 04/08/1982SE |
| K800976 | M.R. Assoc. W Type Grasping ForcepsOCZ · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800972 | M.R. Assoc. Tripod Grasping ForcepsOCZ · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800970 | M.R. Assoc. Basket RetrieversOCZ · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800969 | M.R. Assoc. CannulasOCZ · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800968 | M.R. Assoc. Rat Tooth Grasp ForcepsOCZ · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K800967 | M.R. Assoc. Alligator Graspong ForcepsOCZ · Traditional | Mr Associates, Inc. | 05/08/1980SE |
| K792345 | Retrievable ForcepsOCZ · Traditional | Mill-Rose Laboratory | 12/20/1979SE |
| K760180 | Forceps, GraspingOCZ · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 12/02/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0070-2023 Class II | Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLYDevice label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0069-2023 Class II | Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLYDevice label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0068-2023 Class II | Hobbs Medical Polypectomy Snare Catalog Number: 4563-OLYDevice label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0067-2023 Class II | Hobbs Medical Polypectomy Snare Catalog Number: 7202Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0036-2023 Class II | Hobbs Retrieval Forceps Catalog Number: 5018Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0035-2023 Class II | Hobbs Medical Grasping Forceps Catalog Number: 5008Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0034-2023 Class II | Hobbs Medical Grasping Forceps Catalog Number:5004Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0033-2023 Class II | Hobbs Helical Retrieval Basket Catalog Number: 4832Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0032-2023 Class II | Hobbs Helical Retrieval Basket Catalog Number: 4830Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0031-2023 Class II | Hobbs Helical Retrieval Basket Catalog Number: 4824Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0030-2023 Class II | Hobbs Helical Retrieval Basket Catalog Number: 4822Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0029-2023 Class II | Hobbs Helical Retrieval Basket Catalog Number: 4816Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0028-2023 Class II | Hobbs Helical Retrieval Basket Catalog Number: 4814Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0027-2023 Class II | Hobbs Helical Retrieval Basket Catalog Number: 4808Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0026-2023 Class II | Hobbs Helical Retrieval Basket Catalog Number: 4806Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0016-2023 Class II | Hobbs Medical Polypectomy Snare Catalog Number: 4564Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0015-2023 Class II | Hobbs Medical Polypectomy Snare Catalog Number: 4563Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-1388-2022 Class II | Hobbs Medical Polypectomy Snare, Catalog No. 7202During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink… | Hobbs Medical, Inc. | 06/03/2022Open, Classified |
| Z-2230-2021 Class II | Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226…Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may… | Shent USA, Inc. | 01/12/2021Completed |
| Z-2229-2021 Class II | Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended…Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may… | Shent USA, Inc. | 01/12/2021Completed |
| Z-1453-2015 Class II | Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies…A wire component on the distal grasping assembly of the device became detached.. | US Endoscopy Group Inc | 03/10/2015Terminated |