Cleared Traditional

K905454 - ADVANCE SUTURE NONABSORBABLE SILK SUTURE

K905454 is an FDA 510(k) clearance for ADVANCE SUTURE NONABSORBABLE SILK SUTURE, manufactured by Advance Suture, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K905454 · Advance Suture, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1991
Decision
205d
Days
Class 2
Risk

K905454 is an FDA 510(k) clearance for the ADVANCE SUTURE NONABSORBABLE SILK SUTURE. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by Advance Suture, Inc. (Tucson, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 205 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5030 - 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 Advance Suture, Inc. devices

FDA 510(k) Submission Details - K905454

510(k) Number K905454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1990
Decision Date June 28, 1991
Days to Decision 205 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
90d slower than avg
Panel avg: 115d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAP Suture, Nonabsorbable, Silk

All 31
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K905454.
SILK NONABSORBABLE SURGICAL SUTURES USP
K960328 · R. K. Medical L. L. C. · Mar 1996
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
K930739 · Deknatel, Inc. · Jul 1994
VISITEC PRECISE-POINT
K942234 · Visitec Co. · Jul 1994
NONABSORBABLE SILK SURGICAL SUTURE
K904478 · United States Surgical, A Division of Tyco Healthc · Nov 1990
NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)
K904891 · United States Surgical, A Division of Tyco Healthc · Nov 1990
AIRWAY PRESSURE MONITOR
K761199 · Draeger Medical, Inc. · Feb 1977