BWH — Forceps, Biopsy, Bronchoscope (Non-Rigid) Class II

FDA Device Classification

Classification Details

Product Code
BWH
Device Class
Class II
Regulation Number
874.4680
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252921boston scientific corporationRadial Jaw 4 Pulmonary Biopsy ForcepsSeptember 26, 2025
K121186boston scientificRADIAL JAW 4 PULMONARY BIOPSY FORCEPSMay 16, 2012
K102336boston scientific corporationRADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY January 24, 2011
K022398ballard medical productsREUSABLE BRONCHIAL BIOPSY FORCEPSOctober 11, 2002
K930419wiltek medicalWILTEK BIOPSY FORCEPSJune 1, 1993
K843282rush hampton industriesUNIVERSAL BY RUSH-HAMPTON ARTHROSCOPICOctober 22, 1984