Cleared Abbreviated

CAPROSYN ABSORBABLE SUTURE (K032586) - 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · 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 61
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K032586.
AESCULAP NOVOSYN ABSORBABLE SUTURE
K122734 · Aesculap, Inc. · Dec 2012
MONOCRYL PLUS ANTIBACTERIAL SUTURE
K050845 · Ethicon, Inc. · Jun 2005
MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE
K033746 · Ethicon, Inc. · Dec 2003
MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K032420 · Ethicon, Inc. · Oct 2003
SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE
K031286 · Aesculap, Inc. · May 2003
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE
K022715 · Ethicon, Inc. · Dec 2002