Surgical Instruments, G-U, Manual (And Accessories)
FDA product code KOA · Class I (low risk) · 21 CFR 876.4730 · Gastroenterology, Urology
44510(k) clearances
0PMA approvals
6recalls
Manufacturers
- The Huxley Instrument Corp. 5
- Imm Enterprises , Ltd. 4
- Lone Star Medical Products, Inc. 3
- V. Mueller O.V. Baxter Healthcare Corp. 3
- Cook Urological, Inc. 2
- J. Sklar Mfg. Co., Inc. 2
- Keymed, Inc. 1
- Agency For Medical Innovations GmbH 1
- Martin Medical 1
- Effner and Spreine Co. 1
- Van-Tec, Inc. 1
- Premier Dental Products Co. 1
- Pudenz-Schulte Medical Research Corp. 1
- American Convertors Div., American Pharmaseal 1
- Midwest Metabolic Support Group 1
- Surgemed Marketing, Inc. 1
- Dacomed Corp. 1
- Biomet, Inc. 1
- American V. Mueller 1
- Kendall Research Center 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182664 | FiXcisionKOA · Traditional | Agency For Medical Innovations GmbH | 12/07/2018SE |
| K950267 | Urethral Suture GuideKOA · Traditional | Applied Medical Resources | 01/31/1995SE |
| K932465 | Li VasectomyKOA · Traditional | Femcare , Ltd. | 03/02/1994SE |
| K921546 | Vasovasostomy SetKOA · Traditional | Cook Urological, Inc. | 07/02/1993SESK |
| K931181 | Vesitec Suture PasserKOA · Traditional | Vesitec Medical, Inc. | 05/12/1993SE |
| K921304 | DDV LigatorKOA · Traditional | North American Medical, Inc. | 10/05/1992SE |
| K922971 | No-Scalpel Vascetomy InstrumentsKOA · Traditional | Pilling Co. | 09/23/1992SE |
| K921228 | Benderev Protect-A-Pass NeedleKOA · Traditional | Eimark Labs, Inc. | 09/14/1992SE |
| K922192 | Vas DilatorKOA · Traditional | Cook Urological, Inc. | 08/07/1992SE |
| K896058 | Grasping ForcepsKOA · Traditional | Annex Medical, Inc. | 12/28/1989SE |
| K891352 | Marlow Anal SpeculumKOA · Traditional | Simpson/Basye, Inc. | 06/23/1989SE |
| K890218 | Microsurgical CystotomeKOA · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K864963 | Stomach Evaculator - Ewald StyleKOA · Traditional | Medovations, Inc. | 10/14/1987SE |
| K863273 | Martin Medical Pro-Scope AnoscopeKOA · Traditional | Martin Medical | 11/04/1986SE |
| K852014 | Effner Sims Rectal Speculum W/Fiber Optic IlluminaKOA · Traditional | Effner and Spreine Co. | 08/07/1985SE |
| K852726 | Allis Tissue Forceps, 4X5 Teeth, 6+SS 410 or 420KOA · Traditional | The Huxley Instrument Corp. | 07/09/1985SE |
| K852725 | Babcock Tissue Forceps, 6-1/4 + SS 410 or 420KOA · Traditional | The Huxley Instrument Corp. | 07/09/1985SE |
| K851162 | Al Askari Percutaneous Access Needle HolderKOA · Traditional | Van-Tec, Inc. | 04/15/1985SE |
| K851113 | Randall Kidney Stone Forceps 817-144 Pcs. Full CurKOA · Traditional | The Huxley Instrument Corp. | 04/03/1985SE |
| K851112 | Randall Kidney Stone Forceps 817-144 Pcs. QuarterKOA · Traditional | The Huxley Instrument Corp. | 04/03/1985SE |
| K851111 | Randall Kidney Stone Forceps 817-84 Pcs. Half CurvKOA · Traditional | The Huxley Instrument Corp. | 04/03/1985SE |
| K841387 | Weston Rectal SnareKOA · Traditional | Imm Enterprises , Ltd. | 05/09/1984SE |
| K834171 | Op-Con Surg. Instrument #3KOA · Traditional | Imm Enterprises , Ltd. | 04/04/1984SE |
| K834192 | Jakobi Surg. Instruments #3 21/22/24KOA · Traditional | Imm Enterprises , Ltd. | 03/22/1984SE |
| K834191 | Jakobi Surgical Instruments #3 17/18/19KOA · Traditional | Imm Enterprises , Ltd. | 03/22/1984SE |
| K841003 | Probes, VariousKOA · Traditional | Premier Dental Products Co. | 03/20/1984SE |
| K832677 | P-S Medical Berlin Visaduct KitKOA · Traditional | Pudenz-Schulte Medical Research Corp. | 12/08/1983SE |
| K830786 | Disimetric Release of Instranetics RadKOA · Traditional | American Convertors Div., American Pharmaseal | 05/18/1983SE |
| K822401 | St. Mark's Rectal Biopsy ForcepsKOA · Traditional | Keymed, Inc. | 08/27/1982SE |
| K820015 | Urethal Cutter ClampKOA · Traditional | Lone Star Medical Products, Inc. | 02/22/1982SE |
| K813504 | Acessory to Modified Freeding JejunostoKOA · Traditional | Midwest Metabolic Support Group | 01/07/1982SE |
| K811973 | Forder RetractorKOA · Traditional | Surgemed Marketing, Inc. | 07/31/1981SE |
| K811693 | Forder RetractorKOA · Traditional | Dacomed Corp. | 06/26/1981SE |
| K811223 | Vasovasostomy Stabilizer Platform DevKOA · Traditional | Biomet, Inc. | 05/21/1981SE |
| K810915 | The Scott DialmenzensertKOA · Traditional | Lone Star Medical Products, Inc. | 05/08/1981SE |
| K810533 | Circle Nephrostomy Tube IntroducerKOA · Traditional | American V. Mueller | 03/11/1981SE |
| K802983 | The Inquinal Resorvoir InserterKOA · Traditional | Lone Star Medical Products, Inc. | 12/30/1980SE |
| K801273 | Magill Catheter Intro. ForcepsKOA · Traditional | J. Sklar Mfg. Co., Inc. | 07/28/1980SE |
| K800441 | Rudd-Clinic Hemorrhoidal ForcepsKOA · Traditional | J. Sklar Mfg. Co., Inc. | 04/08/1980SE |
| K772134 | Syringe, Irrigation, Pre-FilledKOA · Traditional | Kendall Research Center | 11/28/1977SE |
| K761229 | Anal/Rectal SyringeKOA · Traditional | Ace Orthopedic Manufacturing Co. | 02/24/1977SE |
| K760717 | Flexible Biopsy ForcepsKOA · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 10/21/1976SE |
| K760715 | Flexible Cutting ScissorsKOA · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 10/21/1976SE |
| K760716 | Flexible Foreign Body ForcepsKOA · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 10/15/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1482-2022 Class II | PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH.…Endoscopic graspers may become separated at the weld from handle to the shaft of the device. | Aesculap Implant Systems LLC | 04/01/2020Completed |
| Z-1481-2022 Class II | PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product…Endoscopic graspers may become separated at the weld from handle to the shaft of the device. | Aesculap Implant Systems LLC | 04/01/2020Completed |
| Z-1808-2020 Class II | ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical…Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets.… | Uromedica Inc. | 04/10/2019Terminated |
| Z-2312-2017 Class II | Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene…COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do… | Cook Inc. | 05/01/2017Terminated |
| Z-2311-2017 Class II | Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in…COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do… | Cook Inc. | 05/01/2017Terminated |
| Z-2310-2017 Class II | Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene…COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do… | Cook Inc. | 05/01/2017Terminated |