Cleared Traditional

K903174 - ADVANCE SUTURE ABSORBABLE GUT SUTURE

K903174 is an FDA 510(k) clearance for ADVANCE SUTURE ABSORBABLE GUT SUTURE, manufactured by Advance Suture, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAE cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K903174 · Advance Suture, Inc. · General & Plastic Surgery device
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Jul 1991
Decision
357d
Days
Class 1
Risk

K903174 is an FDA 510(k) clearance for the ADVANCE SUTURE ABSORBABLE GUT SUTURE. Classified as Snare, Surgical (product code GAE), Class I - General Controls.

Submitted by Advance Suture, Inc. (Tucson, US). The FDA issued a Cleared decision on July 10, 1991 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Advance Suture, Inc. devices

FDA 510(k) Submission Details - K903174

510(k) Number K903174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date July 10, 1991
Days to Decision 357 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
242d slower than avg
Panel avg: 115d · This submission: 357d
Pathway characteristics
Predicate-based equivalence.

GAE Device Classification - Class 1, General Controls

Product Code GAE Snare, Surgical
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.