Submission Details
| 510(k) Number | K932465 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 1993 |
| Decision Date | March 02, 1994 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
Cleared
Traditional
LI VASECTOMY
Mar 1994
Decision
285d
Days
Class 1
Risk
About This 510(k) Submission
K932465 is an FDA 510(k) clearance for the LI VASECTOMY, a Surgical Instruments, G-u, Manual (and Accessories) (Class I — General Controls, product code KOA), submitted by Femcare , Ltd. (Ng7 3en England, GB). The FDA issued a Cleared decision on March 2, 1994, 285 days after receiving the submission on May 21, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.
Device Classification
| Product Code | KOA — Surgical Instruments, G-u, Manual (and Accessories) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.4730 |
Manufacturer
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