Cleared Traditional

K900956 - GS-7100 CHOLANGIOGRAM CLAMP

K900956 is an FDA 510(k) clearance for GS-7100 CHOLANGIOGRAM CLAMP, manufactured by Solos Endoscopy, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDJ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K900956 · Solos Endoscopy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
50d
Days
Class 1
Risk

K900956 is an FDA 510(k) clearance for the GS-7100 CHOLANGIOGRAM CLAMP, 5MM. Classified as Clamp, Surgical, General & Plastic Surgery (product code GDJ), Class I - General Controls.

Submitted by Solos Endoscopy, Inc. (Norcross, US). The FDA issued a Cleared decision on April 18, 1990 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Solos Endoscopy, Inc. devices

FDA 510(k) Submission Details - K900956

510(k) Number K900956 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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

GDJ Device Classification - Class 1, General Controls

Product Code GDJ Clamp, Surgical, General & Plastic Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GDJ Clamp, Surgical, General & Plastic Surgery

All 16
Devices cleared under the same product code (GDJ) and FDA review panel - the closest regulatory comparables to K900956.
THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE
K930315 · Thomasville Medical Assoc. · Feb 1994
MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC
K901107 · United States Surgical, A Division of Tyco Healthc · Apr 1990
SURGICAL DUCT CLAMP (VINE)
K882169 · Henley Intl. · Jun 1988
AUTO SUTURE PURSE STRING APPLIER*
K874428 · United States Surgical, A Division of Tyco Healthc · Dec 1987
TOURIQUET KIT WITH SNARE
K855144 · Dlp, Inc. · Feb 1986
BACKHAUS TOWEL CLAMP, 5-1/2 + SS 410 OR 420
K852724 · The Huxley Instrument Corp. · Jul 1985