K252722 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 Fehling Instruments GmbH (Karlstein, DE). The FDA issued a Cleared decision on September 30, 2025, 33 days after receiving the submission on August 28, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4075.
| 510(k) Number | K252722 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2025 |
| Decision Date | September 30, 2025 |
| Days to Decision | 33 days |
| Submission Type | Special |
| 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 |