K934315 is an FDA 510(k) clearance for the ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME. This device is classified as a Unit, Electrosurgical, Endoscopic (with Or Without Accessories) (Class II — Special Controls, product code KNS).
Submitted by Endovations (Reading, US). The FDA issued a Cleared decision on February 28, 1994, 180 days after receiving the submission on September 1, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K934315 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 01, 1993 |
| Decision Date | February 28, 1994 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNS — Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.4300 |