Cleared Special

K142656 - Surgical Gut Suture

K142656 is an FDA 510(k) clearance for Surgical Gut Suture, manufactured by Covidien. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Special 510(k) pathway after a 133-day FDA review.

K142656 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
133d
Days
Class 2
Risk

K142656 is an FDA 510(k) clearance for the Surgical Gut Suture. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on January 29, 2015 after a review of 133 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4830 - 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. Standard predicate reliance. 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 - K142656

510(k) Number K142656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2014
Decision Date January 29, 2015
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Modification to existing cleared device.

GAL Device Classification - Class 2, Special Controls

Product Code GAL Suture, Absorbable, Natural
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4830
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 - GAL Suture, Absorbable, Natural

All 28
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K142656.
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
K072930 · Demetech Corp. · Apr 2008
UNIPLAIN & UNICHROM
K042287 · United Medical Industries Co. , Ltd. · Sep 2005
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
K042897 · Ethicon Endo-Surgery, Inc. · Nov 2004
SUTURTEK FASTCLOSE SUTURING DEVICE
K030227 · Suturtek Incorporated · Mar 2003
SERRALGUT
K020597 · Serral, S.A. DE C.V. · Aug 2002
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
K021043 · Gramsmed, LLC · Jun 2002
K142656 · Surgical Gut Suture
Download PDF FDA Summary Covidien