Cleared Traditional

USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE (K961997) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961997 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Jul 1996
Decision
55d
Days
Class 2
Risk

K961997 is an FDA 510(k) clearance for the USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on July 16, 1996 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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.

View all United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K961997 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 22, 1996
Decision Date July 16, 1996
Days to Decision 55 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
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 61
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K961997.
ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED
K964345 · Ethicon, Inc. · Dec 1996
SYNTHETIC ABSORBABLE SURGICAL SUTURE
K963253 · United States Surgical, A Division of Tyco Healthc · Oct 1996
COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED
K962480 · Ethicon, Inc. · Aug 1996
POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE
K953869 · United States Surgical, A Division of Tyco Healthc · Oct 1995
USSC MONOFILAMENT POLYSORB SUTURE
K945285 · United States Surgical, A Division of Tyco Healthc · Aug 1995
USSC POLYSORB SUTURE
K951520 · United States Surgical, A Division of Tyco Healthc · Aug 1995