K950982 is an FDA 510(k) clearance for the B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLE, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on April 4, 1995, 32 days after receiving the submission on March 3, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K950982 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 1995 |
| Decision Date | April 04, 1995 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCG — Biopsy Needle |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1075 |