Cleared Special

RADIAL JAW 4 PULMONARY BIOPSY FORCEPS

K121186 · Boston Scientific Corp · Ear, Nose, Throat

May 2012

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K121186 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 Corp (Marborough, US). The FDA issued a Cleared decision on May 16, 2012, 28 days after receiving the submission on April 18, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K121186 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2012
Decision Date	May 16, 2012
Days to Decision	28 days
Submission Type	Special
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).