K201808 is an FDA 510(k) clearance for the X-Tack Endoscopic HeliX Tacking System. This device is classified as a Hemostatic Metal Clip For The Gi Tract (Class II - Special Controls, product code PKL).
Submitted by Apollo Endosurgery, Inc. (Austin, US). The FDA issued a Cleared decision on December 15, 2020, 167 days after receiving the submission on July 1, 2020.
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 | K201808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2020 |
| Decision Date | December 15, 2020 |
| Days to Decision | 167 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. |