Cleared Traditional

RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE

K102336 · Boston Scientific Corporation · Ear, Nose, Throat
Jan 2011
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K102336 is an FDA 510(k) clearance for the RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE, a Forceps, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BWH), submitted by Boston Scientific Corporation (El Coyol,Alajuela, CR). The FDA issued a Cleared decision on January 24, 2011, 159 days after receiving the submission on August 18, 2010. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number K102336 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2010
Decision Date January 24, 2011
Days to Decision 159 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
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).