Cleared Special

Biopsy Forceps

K252722 · Fehling Instruments GmbH · Cardiovascular
Sep 2025
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K252722 is an FDA 510(k) clearance for the Biopsy Forceps, 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 review panel. Regulated under 21 CFR 870.4075.

Submission Details

510(k) Number K252722 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DWZ — Device, Biopsy, Endomyocardial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4075