Cleared Traditional

K001440 - NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

K001440 is an FDA 510(k) clearance for NEXTSTITCH CARDIOVASCULAR VALVE SUTURE, manufactured by Genzyme Surgical Product (Genzyme Biosurgery). The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K001440 · Genzyme Surgical Product (Genzyme Biosurgery) · General & Plastic Surgery device
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Nov 2000
Decision
189d
Days
Class 2
Risk

K001440 is an FDA 510(k) clearance for the NEXTSTITCH CARDIOVASCULAR VALVE SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Genzyme Surgical Product (Genzyme Biosurgery) (Fall River, US). The FDA issued a Cleared decision on November 13, 2000 after a review of 189 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Genzyme Surgical Product (Genzyme Biosurgery) devices

FDA 510(k) Submission Details - K001440

510(k) Number K001440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2000
Decision Date November 13, 2000
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
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 121
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K001440.
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
POLYESTER NONABSORBABLE SURGICAL SUTURES URP
K001172 · Cp Medical · Jun 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