Cleared Traditional

K902400 - WILSON-COOK RETRIEVAL & GRASPING FORCEPS (FDA 510(k) Clearance)

Aug 1990
Decision
69d
Days
Class 2
Risk

K902400 is an FDA 510(k) clearance for the WILSON-COOK RETRIEVAL & GRASPING FORCEPS. This device is classified as a Endoscopic Grasping/cutting Instrument, Non-powered (Class II - Special Controls, product code OCZ).

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on August 7, 1990, 69 days after receiving the submission on May 30, 1990.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope..

Submission Details

510(k) Number K902400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date August 07, 1990
Days to Decision 69 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code OCZ — Endoscopic Grasping/cutting Instrument, Non-powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Manually Grasp Stones, Tissues Or Other Objects Through An Endoscope. To Manipulate, Sample Or Cut Tissues Through An Endoscope.