510(k) K252921

Radial Jaw 4 Pulmonary Biopsy Forceps by Boston Scientific Corporation — Product Code BWH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 26, 2025
Date Received: September 12, 2025
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Forceps, Biopsy, Bronchoscope (Non-Rigid)
Device Class: Class II
Regulation Number: 874.4680
Review Panel: EN
Submission Type

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).

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510(k) K252921

Clearance Details

Device Classification

Other clearances by Boston Scientific Corporation

Other clearances for product code BWH