Cleared Traditional

K022664 - PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.

K022664 is an FDA 510(k) clearance for PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE..., manufactured by Arc Medical Supplies (Beijing) Co, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K022664 · Arc Medical Supplies (Beijing) Co, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
32d
Days
Class 2
Risk

K022664 is an FDA 510(k) clearance for the PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Arc Medical Supplies (Beijing) Co, Ltd. (New Berlin, US). The FDA issued a Cleared decision on September 10, 2002 after a review of 32 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 Arc Medical Supplies (Beijing) Co, Ltd. devices

FDA 510(k) Submission Details - K022664

510(k) Number K022664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2002
Decision Date September 10, 2002
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 115
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K022664.
VISORB SWIFT
K023710 · Cp Medical · Jan 2003
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K022715 · Ethicon, Inc. · Dec 2002
COATED VICRYL* (POLYGLACTIN 910) SUTURE
K022269 · Ethicon, Inc. · Sep 2002
SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED
K014021 · Surgical Specialties Corp · Jan 2002
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