Cleared Traditional

K032468 - SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE

K032468 is an FDA 510(k) clearance for SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE, manufactured by Suturtek Incorporated. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K032468 · Suturtek Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
43d
Days
Class 2
Risk

K032468 is an FDA 510(k) clearance for the SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Suturtek Incorporated (Hopkonton, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - 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 Suturtek Incorporated devices

FDA 510(k) Submission Details - K032468

510(k) Number K032468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2003
Decision Date September 23, 2003
Days to Decision 43 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
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAQ Device Classification - Class 2, Special Controls

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
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 - GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

All 17
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K032468.
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767 · Ethicon, Inc. · Nov 2017
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
K042606 · Synthes (Usa) · May 2005
SYNTHES (USA) TITANIUM WIRE
K041333 · Synthes (Usa) · Aug 2004
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
K030351 · Cp Medical · Mar 2003
STEELEX STERNUM SET
K023411 · Aesculap, Inc. · Dec 2002
ACIER SUTURES
K991073 · Cardio Thoracic Systems · Jul 1999