Cleared Traditional

K900951 - GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP
(FDA 510(k) Clearance)

Apr 1990
Decision
50d
Days
Class 1
Risk

K900951 is an FDA 510(k) clearance for the GS-7000 CLIP-APPLYING FORCEP, 10MM, MEDIUM CLIP. This device is classified as a Forceps, General & Plastic Surgery (Class I - General Controls, product code GEN).

Submitted by Solos Endoscopy, Inc. (Norcross, US). The FDA issued a Cleared decision on April 18, 1990, 50 days after receiving the submission on February 27, 1990.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K900951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date April 18, 1990
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code GEN — Forceps, General & Plastic Surgery
Device Class Class I - General Controls
CFR Regulation 21 CFR 878.4800