Cleared Traditional

WILTEK BIOPSY FORCEPS

K930419 · Wiltek Medical, Inc. · Ear, Nose, Throat

Jun 1993

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K930419 is an FDA 510(k) clearance for the WILTEK BIOPSY FORCEPS, a Forceps, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BWH), submitted by Wiltek Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on June 1, 1993, 126 days after receiving the submission on January 26, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K930419 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 1993
Decision Date	June 01, 1993
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

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).