Cleared Traditional

K000542 - PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP

K000542 is an FDA 510(k) clearance for PLAIN AND CHRONIC GUT ABSORBABLE SURGIC..., manufactured by Arc Medical Supplies (Beijing) Co, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K000542 · Arc Medical Supplies (Beijing) Co, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
71d
Days
Class 2
Risk

K000542 is an FDA 510(k) clearance for the PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Arc Medical Supplies (Beijing) Co, Ltd. (Syosset, US). The FDA issued a Cleared decision on April 28, 2000 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4830 - 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 - K000542

510(k) Number K000542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2000
Decision Date April 28, 2000
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAL Device Classification - Class 2, Special Controls

Product Code GAL Suture, Absorbable, Natural
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4830
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 - GAL Suture, Absorbable, Natural

All 17
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K000542.
Surgical Gut Suture
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K001299 · Cp Medical · Jun 2000
LIGA-LOOP SUTURE APPLICATOR
K993695 · Hysterx, Inc. · Apr 2000
PLAIN/CHROMIC CATGUT
K994002 · Trading Consultants and Distributors Intl., Inc. · Feb 2000
AILEE SUTURES AND AILEE NEEDLES
K982646 · Myco Medical Supplies, Inc. · Jun 1999