Cleared Traditional

K903029 - STERILE BLACK MONOFILAMENT NYLON NON-AB...

K903029 is the FDA 510(k) clearance for STERILE BLACK MONOFILAMENT NYLON NON-AB... by Look, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAR) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K903029 · Look, Inc. · General & Plastic Surgery device
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Oct 1990
Decision
107d
Days
Class 2
Risk

K903029 is an FDA 510(k) clearance for the STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Look, Inc. (Washington, US). The FDA issued a Cleared decision on October 25, 1990 after a review of 107 days - within the typical 510(k) review window.

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. 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 Look, Inc. devices

Submission Details

510(k) Number K903029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1990
Decision Date October 25, 1990
Days to Decision 107 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
8d faster than avg
Panel avg: 115d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K903029.
URESIL LOCKING GENERAL PURPOSE DRAINAGE CATHETER
K920510 · Uresil Corp. · Sep 1992
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
K904931 · United States Surgical, A Division of Tyco Healthc · Jan 1991
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
K905379 · United States Surgical, A Division of Tyco Healthc · Jan 1991
NONABSORBABLE NYLON SURGICAL SUTURE*
K900531 · United States Surgical, A Division of Tyco Healthc · Jul 1990