Cleared Traditional

K926199 - UNICLIP SURGICAL CLIP APPLIER

K926199 is an FDA 510(k) clearance for UNICLIP SURGICAL CLIP APPLIER, manufactured by Unisurge, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDO cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K926199 · Unisurge, Inc. · General & Plastic Surgery device
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Apr 1993
Decision
132d
Days
Class 1
Risk

K926199 is an FDA 510(k) clearance for the UNICLIP SURGICAL CLIP APPLIER. Classified as Applier, Surgical, Clip (product code GDO), Class I - General Controls.

Submitted by Unisurge, Inc. (Cupertino, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Unisurge, Inc. devices

FDA 510(k) Submission Details - K926199

510(k) Number K926199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1992
Decision Date April 20, 1993
Days to Decision 132 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

GDO Device Classification - Class 1, General Controls

Product Code GDO Applier, Surgical, Clip
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 - GDO Applier, Surgical, Clip

All 10
Devices cleared under the same product code (GDO) and FDA review panel - the closest regulatory comparables to K926199.
MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP
K890941 · United States Surgical, A Division of Tyco Healthc · Apr 1989
SUTURE CLIP APPLIER/REMOVER
K890233 · Kinetic Medical Products · Jan 1989
DISPOSABLE MULTIPLE LIGATING CLIP
K820837 · Ethicon, Inc. · May 1982
ETHICON MULTIPLE LIGATING CLIP APPLIER
K812291 · Ethicon, Inc. · Sep 1981
HEMOSPENSER CARTRIDGE CAT. NO. 523500-
K792378 · Edward Weck, Inc. · Dec 1979
BAYONET HEIFETZ CLIP APPLIERS
K791845 · Edward Weck, Inc. · Oct 1979