K970356 is an FDA 510(k) clearance for the IRRIGATION/ASPIRATION POLYPECTOMY. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on March 25, 1997, 54 days after receiving the submission on January 30, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K970356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1997 |
| Decision Date | March 25, 1997 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDI - Snare, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |