Cleared Traditional

GRAMSORB SYNTHETIC ABSORBABLE SUTURE (K003017) - FDA 510(k) Clearance

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

K003017 · Gramsmed, LLC · General & Plastic Surgery device
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Mar 2001
Decision
167d
Days
Class 2
Risk

K003017 is an FDA 510(k) clearance for the GRAMSORB SYNTHETIC ABSORBABLE SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Gramsmed, LLC (Grafton, US). The FDA issued a Cleared decision on March 13, 2001 after a review of 167 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 Gramsmed, LLC devices

Submission Details

510(k) Number K003017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2000
Decision Date March 13, 2001
Days to Decision 167 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
52d slower than avg
Panel avg: 115d · This submission: 167d
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 62
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K003017.
L-25 ABSORBABLE SURIGCAL SUTURE
K013671 · United States Surgical, A Division of Tyco Healthc · Jan 2002
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011372 · Aesculap, Inc. · Aug 2001
AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE
K011375 · Aesculap, Inc. · Jun 2001
MONOFILAMENT BIOSYN SUTURE
K000037 · United States Surgical, A Division of Tyco Healthc · Mar 2000
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
K990951 · United States Surgical, A Division of Tyco Healthc · Apr 1999
POLYSORB SUTURE
K981935 · United States Surgical, A Division of Tyco Healthc · Jun 1998