DISPOSABLE H-PE MICROKERATOME BLADES— 510(k) K001464

Substantially Equivalent

Oasis

FDA 510(k) clearance K001464 for DISPOSABLE H-PE MICROKERATOME BLADES, Substantially Equivalent on 2000-10-02. Applicant: Oasis.

Clearance details

Applicant: Oasis
Product code: Code HNO
Advisory panel: Ophthalmic
Date received: 2000-05-10
Decision date: 2000-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

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.