Cleared Traditional

K904054 - POLYVIOLENE(TM) SUTURE

K904054 is an FDA 510(k) clearance for POLYVIOLENE(TM) SUTURE, manufactured by Look, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAS cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K904054 · Look, Inc. · General & Plastic Surgery device
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Oct 1990
Decision
64d
Days
Class 2
Risk

K904054 is an FDA 510(k) clearance for the POLYVIOLENE(TM) SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyester (product code GAS), Class II - Special Controls.

Submitted by Look, Inc. (Ada, US). The FDA issued a Cleared decision on October 3, 1990 after a review of 64 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K904054

510(k) Number K904054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date October 03, 1990
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAS Device Classification - Class 2, Special Controls

Product Code GAS Suture, Nonabsorbable, Synthetic, Polyester
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.

K904054 · POLYVIOLENE(TM) SUTURE
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