Cleared Traditional

K931916 - SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER

K931916 is an FDA 510(k) clearance for SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER, manufactured by Surgimetrics International, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K931916 · Surgimetrics International, Ltd. · General & Plastic Surgery device
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Mar 1994
Decision
321d
Days
Class 2
Risk

K931916 is an FDA 510(k) clearance for the SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Surgimetrics International, Ltd. (Norcross, US). The FDA issued a Cleared decision on March 3, 1994 after a review of 321 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 878.5000 - 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 Surgimetrics International, Ltd. devices

FDA 510(k) Submission Details - K931916

510(k) Number K931916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1993
Decision Date March 03, 1994
Days to Decision 321 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
206d slower than avg
Panel avg: 115d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 166
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K931916.
USSC NONABSORBABLE SUTURES
K955747 · United States Surgical, A Division of Tyco Healthc · Feb 1996
ACUFEX ENDOBUTTON TAPE
K952535 · Acufex Microsurgical, Inc. · Feb 1996
POLYVIOLENE SURGICL SUTURE
K943949 · Look, Inc. · Nov 1994
POLYVIOLENE SUTURE-REVISED LABELING
K926167 · Look, Inc. · Dec 1993
SILK SUTURES
K930590 · Davis & Geck, Inc. · Dec 1993
TI-CRON AND DACRON SUTURES
K930591 · Davis & Geck, Inc. · Dec 1993