K183309 is an FDA 510(k) clearance for the stentfix OTSC System Set, a Hemostatic Metal Clip For The Gi Tract (Class II — Special Controls, product code PKL), submitted by Ovesco Endoscopy AG (Tuebingen, DE). The FDA issued a Cleared decision on October 22, 2019, 327 days after receiving the submission on November 29, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.
| 510(k) Number | K183309 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 29, 2018 |
| Decision Date | October 22, 2019 |
| Days to Decision | 327 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | PKL — Hemostatic Metal Clip For The Gi Tract |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4400 |
| Definition | Clip Placement Within The Gastrointestinal (gi) Tract For The Purpose Of Endoscopic Marking, Hemostasis For Mucosal/sub-mucosal Defects, Bleeding Ulcers, Arteries, Polyps, Diverticula In The Colon, Prophylactic Clipping, Anchoring Feeding Tubes, Supplemental Closure Method Of Luminal Perforations. |