Cleared Traditional

K020597 - SERRALGUT

K020597 is an FDA 510(k) clearance for SERRALGUT, manufactured by Serral, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAL cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K020597 · Serral, S.A. DE C.V. · General & Plastic Surgery device
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Aug 2002
Decision
173d
Days
Class 2
Risk

K020597 is an FDA 510(k) clearance for the SERRALGUT. Classified as Suture, Absorbable, Natural (product code GAL), Class II - Special Controls.

Submitted by Serral, S.A. DE C.V. (Williamsburg, US). The FDA issued a Cleared decision on August 14, 2002 after a review of 173 days - an extended review 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: 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.

FDA 510(k) Submission Details - K020597

510(k) Number K020597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2002
Decision Date August 14, 2002
Days to Decision 173 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 115d · This submission: 173d
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 K020597.
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
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
K021043 · Gramsmed, LLC · Jun 2002
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
K011105 · Qrc Consulting · May 2001
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
K001299 · Cp Medical · Jun 2000
K020597 · SERRALGUT
Download PDF Serral, S.A. DE C.V.