K101428 is an FDA 510(k) clearance for the OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET. This device is classified as a Hemostatic Metal Clip For The Gi Tract (Class II - Special Controls, product code PKL).
Submitted by Ovesco Endoscopy AG (Karlsruhe, DE). The FDA issued a Cleared decision on December 1, 2010, 194 days after receiving the submission on May 21, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4400. 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..
| 510(k) Number | K101428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2010 |
| Decision Date | December 01, 2010 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |