ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS— 510(k) K925185

Substantially Equivalent

Louis M. Gerson Co., Inc.

FDA 510(k) clearance K925185 for ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS, Substantially Equivalent on 1994-02-03. Applicant: Louis M. Gerson Co., Inc..

Clearance details

Applicant: Louis M. Gerson Co., Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1992-10-14
Decision date: 1994-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleboro, MA, US

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.