Cleared Traditional

K931914 - SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE

K931914 is an FDA 510(k) clearance for SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE, manufactured by Surgimetrics International, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 537-day FDA review.

K931914 · Surgimetrics International, Ltd. · General & Plastic Surgery device
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Oct 1994
Decision
537d
Days
Class 2
Risk

K931914 is an FDA 510(k) clearance for the SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Surgimetrics International, Ltd. (Norcross, US). The FDA issued a Cleared decision on October 5, 1994 after a review of 537 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 878.5020 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Surgimetrics International, Ltd. devices

FDA 510(k) Submission Details - K931914

510(k) Number K931914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1993
Decision Date October 05, 1994
Days to Decision 537 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
422d slower than avg
Panel avg: 115d · This submission: 537d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 40
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K931914.
SURGILON, DERMALON, & OPHTHALON
K981582 · Davis & Geck, Inc. · Jul 1998
CUTALON NYLON POLYAMIDE SURGICAL SUTURE
K981322 · Genzyme Surgical Product (Genzyme Biosurgery) · Jul 1998
NYLON NOABSORBABLE SURGICAL SUTURES USP
K960327 · R. K. Medical L. L. C. · Mar 1996
SILK SUTURES-REVISED LABELING
K926168 · Look, Inc. · Dec 1993
REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)
K926587 · Look, Inc. · Dec 1993
NON-ABSORBABLE SURGICAL SUTURES
K930517 · Alcon Laboratories · Dec 1993