Cleared Traditional

K000540 - POLYESTER NONABSORBABLE SURGICAL SUTURES, USP

K000540 is an FDA 510(k) clearance for POLYESTER NONABSORBABLE SURGICAL SUTURES, manufactured by Arc Medical Supplies (Beijing) Co, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K000540 · Arc Medical Supplies (Beijing) Co, Ltd. · General & Plastic Surgery device
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Apr 2000
Decision
70d
Days
Class 2
Risk

K000540 is an FDA 510(k) clearance for the POLYESTER NONABSORBABLE SURGICAL SUTURES, USP. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Arc Medical Supplies (Beijing) Co, Ltd. (Syosset, US). The FDA issued a Cleared decision on April 27, 2000 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 - K000540

510(k) Number K000540 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 17, 2000
Decision Date April 27, 2000
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 134
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K000540.
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
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K010673 · Arthrex, Inc. · May 2001
POLYESTER NONABSORBABLE SURGICAL SUTURES URP
K001172 · Cp Medical · Jun 2000
POLYESTER
K994000 · Trading Consultants and Distributors Intl., Inc. · Feb 2000
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
K990952 · United States Surgical, A Division of Tyco Healthc · Apr 1999
PRE-THREADED ENDOBUTTON
K984550 · Smith & Nephew, Inc. · Mar 1999