Cleared Special

Radial Jaw 4 Pulmonary Biopsy Forceps

K252921 · Boston Scientific Corporation · Anesthesiology

Sep 2025

Decision

14d

Days

Class 2

Risk

About This 510(k) Submission

K252921 is an FDA 510(k) clearance for the Radial Jaw 4 Pulmonary Biopsy Forceps, a Forceps, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BWH), submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on September 26, 2025, 14 days after receiving the submission on September 12, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K252921 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 2025
Decision Date	September 26, 2025
Days to Decision	14 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	BWH — Forceps, Biopsy, Bronchoscope (non-rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).