Cleared Traditional

K760180 - FORCEPS, GRASPING (FDA 510(k) Clearance)

Dec 1976
Decision
149d
Days
Class 2
Risk

K760180 is an FDA 510(k) clearance for the FORCEPS, GRASPING. This device is classified as a Endoscopic Grasping/cutting Instrument, Non-powered (Class II - Special Controls, product code OCZ).

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1976, 149 days after receiving the submission on July 6, 1976.

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 K760180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date December 02, 1976
Days to Decision 149 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.