Cleared Traditional

K030227 - SUTURTEK FASTCLOSE SUTURING DEVICE

K030227 is an FDA 510(k) clearance for SUTURTEK FASTCLOSE SUTURING DEVICE, manufactured by Suturtek Incorporated. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K030227 · Suturtek Incorporated · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
54d
Days
Class 2
Risk

K030227 is an FDA 510(k) clearance for the SUTURTEK FASTCLOSE SUTURING DEVICE. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Suturtek Incorporated (Hopkonton, US). The FDA issued a Cleared decision on March 17, 2003 after a review of 54 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K030227

510(k) Number K030227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2003
Decision Date March 17, 2003
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 29
Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K030227.
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
SERRALGUT
K020597 · Serral, S.A. DE C.V. · Aug 2002
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
K021043 · Gramsmed, LLC · Jun 2002
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
K011105 · Qrc Consulting · May 2001
K030227 · SUTURTEK FASTCLOSE SUTURING DEVICE
Download PDF FDA Summary Suturtek Incorporated