K974594 is an FDA 510(k) clearance for the SEMKIN BIPOLAR FORCEP, a Forceps (Class I — General Controls, product code HTD), submitted by Titan Mfg., Inc. (Phoenixville, US). The FDA issued a Cleared decision on June 24, 1998, 197 days after receiving the submission on December 9, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K974594 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 09, 1997 |
| Decision Date | June 24, 1998 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | HTD — Forceps |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |