Cleared Abbreviated

K032586 - CAPROSYN ABSORBABLE SUTURE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K032586 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
87d
Days
Class 2
Risk

K032586 is an FDA 510(k) clearance for the CAPROSYN ABSORBABLE 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 November 17, 2003 after a review of 87 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K032586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2003
Decision Date November 17, 2003
Days to Decision 87 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 114d · This submission: 87d
Pathway characteristics
Standards-based clearance path.

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 146
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K032586.
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
Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME)
K232372 · Peters Surgical · Jul 2024