K935457 is an FDA 510(k) clearance for the LOCALIZATION WIRE OR MARKER - SURGICAL, a Guide, Needle, Surgical (Class I — General Controls, product code GDF), submitted by Bip USA, Inc. (Niagara Falls, US). The FDA issued a Cleared decision on February 17, 1994, 97 days after receiving the submission on November 12, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K935457 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 1993 |
| Decision Date | February 17, 1994 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDF — Guide, Needle, Surgical |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 878.4800 |