K921401 is an FDA 510(k) clearance for the BIOPSY FORCEPS. This device is classified as a Device, Biopsy, Endomyocardial (Class II - Special Controls, product code DWZ).
Submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on October 21, 1992, 211 days after receiving the submission on March 24, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4075.
| 510(k) Number | K921401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1992 |
| Decision Date | October 21, 1992 |
| Days to Decision | 211 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWZ — Device, Biopsy, Endomyocardial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4075 |