CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE— 510(k) K103303

Substantially Equivalent

Crosstex International, Inc.

FDA 510(k) clearance K103303 for CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE, Substantially Equivalent on 2010-12-23. Applicant: Crosstex International, Inc..

Clearance details

Applicant: Crosstex International, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2010-11-09
Decision date: 2010-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, 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.