K934370 is an FDA 510(k) clearance for the BIP BIOPSY NEEDLE MODIFICATION, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Bip USA, Inc. (Niagara Falls, US). The FDA issued a Cleared decision on March 7, 1994, 181 days after receiving the submission on September 7, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K934370 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 07, 1993 |
| Decision Date | March 07, 1994 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCG — Biopsy Needle |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1075 |