K970945 is an FDA 510(k) clearance for the ANGLED TIP POLYPECTOMY SNARE. This device is classified as a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II - Special Controls, product code KNS).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on May 7, 1997, 54 days after receiving the submission on March 14, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K970945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1997 |
| Decision Date | May 07, 1997 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNS - Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |