Cleared Traditional

MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE (K081002) - FDA 510(k) Clearance

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

K081002 · Sutures India Pvt., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
62d
Days
Class 2
Risk

K081002 is an FDA 510(k) clearance for the MONOGLYDE, ABSORBABLE (POLIGLECAPRONE 25) SUTURE. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Sutures India Pvt., Ltd. (Bangalore, IN). The FDA issued a Cleared decision on June 9, 2008 after a review of 62 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 Sutures India Pvt., Ltd. devices

Submission Details

510(k) Number K081002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2008
Decision Date June 09, 2008
Days to Decision 62 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
53d faster than avg
Panel avg: 115d · This submission: 62d
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 147
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K081002.
Trexon™ Monofilament Synthetic Absorbable Suture
K253530 · Medtronic · May 2026
MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
K253852 · Ethicon, Inc. · Feb 2026
STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device
K252743 · Ethicon, Inc. · Dec 2025
TroClose 1200
K253620 · Gordian Surgical, Ltd. · Dec 2025
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso)
K252820 · Internacional Farmac?utica S.A DE C.V · Oct 2025
Monotime and Optime R
K233265 · Peters Surgical · Oct 2024