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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K252722

510(k) cleared

Biopsy Forceps

Fehling Instruments GmbH · Sep 30, 2025 · K252722

FDA cleared the Biopsy Forceps from Fehling Instruments GmbH on Sep 30, 2025 under K252722, a special 510(k). The device falls under product code DWZ, Device, Biopsy, Endomyocardial, regulated at 21 CFR 870.4075 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 28, 2025. The decision came 33 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Fehling Instruments GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252722?

K252722 is the FDA 510(k) for Biopsy Forceps, submitted by Fehling Instruments GmbH. FDA's decision date was Sep 30, 2025, under product code DWZ (Device, Biopsy, Endomyocardial).

Who makes the Biopsy Forceps?

Fehling Instruments GmbH, based in Karlstein, is the applicant of record for K252722.

How long did the K252722 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Sep 30, 2025, 33 days later.

← All decisions in September 2025