Cleared Traditional

LIFESTITCH SUTURING DEVICE (K013990) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013990 · Edwards Lifesciences, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Feb 2002
Decision
86d
Days
Class 2
Risk

K013990 is an FDA 510(k) clearance for the LIFESTITCH SUTURING DEVICE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on February 27, 2002 after a review of 86 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 Edwards Lifesciences, LLC devices

Submission Details

510(k) Number K013990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date February 27, 2002
Days to Decision 86 days
Submission Type Traditional
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
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 73
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K013990.
DURABRAID SUTURE
K040789 · Smith & Nephew, Inc. · Jun 2004
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239
K032245 · Arthrex, Inc. · Jan 2004
ARTHREX FIBERWIRE IN USP SIZES
K021434 · Arthrex, Inc. · Nov 2002
ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
K012923 · Arthrex, Inc. · Oct 2001
PREMICRON NONABSORBABLE PET SURGICAL SUTURE
K012201 · Aesculap, Inc. · Sep 2001
ARTHREX FIBERWIRE, MODEL SPU-02NB-3800
K010673 · Arthrex, Inc. · May 2001