K950267 is an FDA 510(k) clearance for the URETHRAL SUTURE GUIDE. This device is classified as a Surgical Instruments, G-u, Manual (and Accessories) (Class I - General Controls, product code KOA).
Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on January 31, 1995, 8 days after receiving the submission on January 23, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K950267 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1995 |
| Decision Date | January 31, 1995 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOA — Surgical Instruments, G-u, Manual (and Accessories) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4730 |