Cleared Traditional

REUSABLE BRONCHIAL BIOPSY FORCEPS

K022398 · Ballard Medical Products · Ear, Nose, Throat

Oct 2002

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K022398 is an FDA 510(k) clearance for the REUSABLE BRONCHIAL BIOPSY FORCEPS, a Forceps, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BWH), submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on October 11, 2002, 80 days after receiving the submission on July 23, 2002. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K022398 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 2002
Decision Date	October 11, 2002
Days to Decision	80 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).