Cleared Traditional

GRAMS POLYESTER NONABSORBABLE SUTURE (K003590) - FDA 510(k) Clearance

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

K003590 · Gramsmed, LLC · General & Plastic Surgery device
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Mar 2001
Decision
104d
Days
Class 2
Risk

K003590 is an FDA 510(k) clearance for the GRAMS POLYESTER NONABSORBABLE SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Gramsmed, LLC (Grafton, US). The FDA issued a Cleared decision on March 5, 2001 after a review of 104 days - within the typical 510(k) review window.

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: 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 Gramsmed, LLC devices

Submission Details

510(k) Number K003590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2000
Decision Date March 05, 2001
Days to Decision 104 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
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.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 73
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K003590.
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ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · Arthrex, Inc. · May 2001
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
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PRE-THREADED ENDOBUTTON
K984550 · Smith & Nephew, Inc. · Mar 1999
SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE
K990088 · Aesculap, Inc. · Feb 1999