K121505 is an FDA 510(k) clearance for the DISPOSABLE HEMOSTASIS CHIP. This device is classified as a Hemostatic Metal Clip For The Gi Tract (Class II - Special Controls, product code PKL).
Submitted by Wilson-Cook Medical Inc./Cook Endoscopy (Winston-Salem, US). The FDA issued a Cleared decision on August 31, 2012, 102 days after receiving the submission on May 21, 2012.
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 | K121505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2012 |
| Decision Date | August 31, 2012 |
| Days to Decision | 102 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. |