SERRALGUT— 510(k) K020597

Name: FDA 510(k) clearance K020597
Creator: U.S. Food and Drug Administration
Published: 2002-08-14

Substantially Equivalent

Serral, S.A. DE C.V.

FDA 510(k) clearance K020597 for SERRALGUT, Substantially Equivalent on 2002-08-14. Applicant: Serral, S.A. DE C.V.. Device class: 2.

Clearance details

Applicant: Serral, S.A. DE C.V.
Product code: Code GAL
Device class: Class 2
Regulation: 21 CFR 878.4830
Advisory panel: General, Plastic Surgery
Date received: 2002-02-22
Decision date: 2002-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Serral, S.A. DE C.V.

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K033762 — SERRALAPG2004-03-15
K020902 — SERRALESTER2002-05-20
K020901 — SERRALSILK2002-04-26
K020146 — SERRALNYL2002-04-15
K020265 — SERRALENE, MODEL CATALOG NO 1S2002-03-08

Adverse events under product code GAL

product code GAL

Malfunction: 681
Other: 1
Total: 682

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.