SERRALENE, MODEL CATALOG NO 1S— 510(k) K020265

Name: FDA 510(k) clearance K020265
Creator: U.S. Food and Drug Administration
Published: 2002-03-08

Substantially Equivalent

Serral, S.A. DE C.V.

FDA 510(k) clearance K020265 for SERRALENE, MODEL CATALOG NO 1S, Substantially Equivalent on 2002-03-08. Applicant: Serral, S.A. DE C.V.. Device class: 2.

Clearance details

Applicant: Serral, S.A. DE C.V.
Product code: Code GAW
Device class: Class 2
Regulation: 21 CFR 878.5010
Advisory panel: General, Plastic Surgery
Date received: 2002-01-25
Decision date: 2002-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, US

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Adverse events under product code GAW

product code GAW

Death: 66
Injury: 1,616
Malfunction: 10,428
Total: 12,110

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.