Cleared Traditional

GS-7100 CHOLANGIOGRAM CLAMP, 5MM

K900956 · Solos Endoscopy, Inc. · General & Plastic Surgery
Apr 1990
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K900956 is an FDA 510(k) clearance for the GS-7100 CHOLANGIOGRAM CLAMP, 5MM, a Clamp, Surgical, General & Plastic Surgery (Class I — General Controls, product code GDJ), 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 review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K900956 FDA.gov
FDA Decision Cleared 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 GDJ — Clamp, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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