K922939 is an FDA 510(k) clearance for the BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT.. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on February 16, 1993, 243 days after receiving the submission on June 18, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K922939 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | June 18, 1992 |
| Decision Date | February 16, 1993 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |