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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 / K252921

510(k) cleared

Radial Jaw 4 Pulmonary Biopsy Forceps

Boston Scientific Corporation · Sep 26, 2025 · K252921

FDA cleared the Radial Jaw 4 Pulmonary Biopsy Forceps from Boston Scientific Corporation on Sep 26, 2025 under K252921, a special 510(k). The device falls under product code BWH, Forceps, Biopsy, Bronchoscope (Non-Rigid), regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Sep 12, 2025. The decision came 14 days later, inside the 90 FDA-day goal for a 510(k).

Boston Scientific Corporation has 8 other decisions in the tracker over the last 12 months: K262406 (EluPro Antibiotic-Eluting BioEnvelope), K261488 (OBSIDIO Conformable Embolic), K262165 (FARADRIVE Steerable Sheath (M004PF21M402)), K262462 (TheraSphere 360 Y-90 Management Platform).

Questions & Answers

What did FDA clear under K252921?

K252921 is the FDA 510(k) for Radial Jaw 4 Pulmonary Biopsy Forceps, submitted by Boston Scientific Corporation. FDA's decision date was Sep 26, 2025, under product code BWH (Forceps, Biopsy, Bronchoscope (Non-Rigid)).

Who makes the Radial Jaw 4 Pulmonary Biopsy Forceps?

Boston Scientific Corporation, based in Marlboro, MA, is the applicant of record for K252921.

How long did the K252921 review take?

FDA received the submission on Sep 12, 2025 and issued its decision on Sep 26, 2025, 14 days later.

← All decisions in September 2025