Cleared Traditional

K930517 - NON-ABSORBABLE SURGICAL SUTURES

K930517 is an FDA 510(k) clearance for NON-ABSORBABLE SURGICAL SUTURES, manufactured by Alcon Laboratories. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K930517 · Alcon Laboratories · General & Plastic Surgery device
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Dec 1993
Decision
319d
Days
Class 2
Risk

K930517 is an FDA 510(k) clearance for the NON-ABSORBABLE SURGICAL SUTURES. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on December 17, 1993 after a review of 319 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: 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 Alcon Laboratories devices

FDA 510(k) Submission Details - K930517

510(k) Number K930517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date December 17, 1993
Days to Decision 319 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 115d · This submission: 319d
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 32
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K930517.
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
DERMALON,SURGILON,OPHTHALON,& OPHTHALMIC NYLON SUT
K930586 · Davis & Geck, Inc. · Dec 1993
NYLAMID SUTURE
K931612 · S. Jackson, Inc. · Dec 1993
SUPRAMID SUTURE
K931613 · S. Jackson, Inc. · Dec 1993