Cleared Traditional

SERRALGUT (K020597) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

View all Serral, S.A. DE C.V. devices

Submission Details

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
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.

Device Classification

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

Devices cleared under the same product code (GAL) and FDA review panel - the closest regulatory comparables to K020597.
ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC
K991223 · Aesculap, Inc. · Apr 1999
SURGICAL SUTURE PACKAGE INSERTS
K930416 · United States Surgical, A Division of Tyco Healthc · Apr 1994
AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP
K904588 · United States Surgical, A Division of Tyco Healthc · Dec 1990
ENDOSCOPIC HEMOSTATIC LIGATING LOOP
K902731 · United States Surgical, A Division of Tyco Healthc · Sep 1990
ABSORBABLE SURGICAL GUT SUTURE*
K885018 · United States Surgical, A Division of Tyco Healthc · Aug 1989