Cleared Special

K082828 - SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE

K082828 is an FDA 510(k) clearance for SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE, manufactured by Suturtek Incorporated. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Special 510(k) pathway after a 19-day FDA review.

K082828 · Suturtek Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
19d
Days
Class 2
Risk

K082828 is an FDA 510(k) clearance for the SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Suturtek Incorporated (Acton, US). The FDA issued a Cleared decision on October 14, 2008 after a review of 19 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082828

510(k) Number K082828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2008
Decision Date October 14, 2008
Days to Decision 19 days
Submission Type Special
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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 31
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K082828.
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
K141007 · Demetech Corp. · Sep 2014
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
K140127 · Pontis Orthopaedics, LLC · May 2014
FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5
K081060 · Core Essence Orthopaedics, LLC · Dec 2008
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
K063603 · Suturtek Incorporated · Feb 2007
MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE
K042606 · Synthes (Usa) · May 2005
SYNTHES (USA) TITANIUM WIRE
K041333 · Synthes (Usa) · Aug 2004
K082828 · SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
Download PDF FDA Summary Suturtek Incorporated