Cleared Traditional

USSC MONOFILAMENT POLYSORB SUTURE (K945285) - FDA 510(k) Clearance

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

K945285 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
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Aug 1995
Decision
294d
Days
Class 2
Risk

K945285 is an FDA 510(k) clearance for the USSC MONOFILAMENT POLYSORB 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 August 21, 1995 after a review of 294 days - an extended review 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: 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K945285 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 31, 1994
Decision Date August 21, 1995
Days to Decision 294 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
179d slower than avg
Panel avg: 115d · This submission: 294d
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 K945285.
COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED
K962480 · Ethicon, Inc. · Aug 1996
USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE
K961997 · United States Surgical, A Division of Tyco Healthc · Jul 1996
POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE
K953869 · United States Surgical, A Division of Tyco Healthc · Oct 1995
USSC POLYSORB SUTURE
K951520 · United States Surgical, A Division of Tyco Healthc · Aug 1995
VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT
K946271 · Ethicon, Inc. · Jun 1995
VICRYL RAPIDE SUTURE
K944110 · Ethicon, Inc. · Jan 1995