Cleared Traditional

K901348 - WILSON-COOK BRONCHOSCOPE BIOPSY FORCEPS (FDA 510(k) Clearance)

Oct 1990
Decision
200d
Days
Class 2
Risk

K901348 is an FDA 510(k) clearance for the WILSON-COOK BRONCHOSCOPE BIOPSY FORCEPS. This device is classified as a Injector, Jet, Gas-powered (Class II - Special Controls, product code EGQ).

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on October 9, 1990, 200 days after receiving the submission on March 23, 1990.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4465.

Submission Details

510(k) Number K901348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1990
Decision Date October 09, 1990
Days to Decision 200 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EGQ — Injector, Jet, Gas-powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 872.4465