K922971 is an FDA 510(k) clearance for the NO-SCALPEL VASCETOMY INSTRUMENTS, a Surgical Instruments, G-u, Manual (and Accessories) (Class I — General Controls, product code KOA), submitted by Pilling Co. (Fort Washington, US). The FDA issued a Cleared decision on September 23, 1992, 96 days after receiving the submission on June 19, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K922971 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 19, 1992 |
| Decision Date | September 23, 1992 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KOA — Surgical Instruments, G-u, Manual (and Accessories) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.4730 |