Cleared Traditional

K010672 - MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE

K010672 is an FDA 510(k) clearance for MONOGRAMS SYNTHETIC MONOFILAMENT ABSORB..., manufactured by Gramsmed, LLC. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K010672 · Gramsmed, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
73d
Days
Class 2
Risk

K010672 is an FDA 510(k) clearance for the MONOGRAMS SYNTHETIC MONOFILAMENT 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 May 18, 2001 after a review of 73 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 Gramsmed, LLC devices

FDA 510(k) Submission Details - K010672

510(k) Number K010672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date May 18, 2001
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAM Device Classification - Class 2, Special Controls

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 116
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K010672.
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
BIOKNOTLESS ANCHOR
K002639 · Mitek Products · May 2001
POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP)
K002190 · Cp Medical · Aug 2000
MONOFILAMENT BIOSYN SUTURE
K000037 · United States Surgical, A Division of Tyco Healthc · Mar 2000