K921304 is an FDA 510(k) clearance for the DDV LIGATOR, a Surgical Instruments, G-u, Manual (and Accessories) (Class I — General Controls, product code KOA), submitted by North American Medical, Inc. (Lubbock, US). The FDA issued a Cleared decision on October 5, 1992, 208 days after receiving the submission on March 11, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K921304 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 11, 1992 |
| Decision Date | October 05, 1992 |
| Days to Decision | 208 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 |