ULTRASONIC FRAGMENTOR— 510(k) K813389

Substantially Equivalent

Fibra Sonics, Inc.

FDA 510(k) clearance K813389 for ULTRASONIC FRAGMENTOR, Substantially Equivalent on 1982-02-04. Applicant: Fibra Sonics, Inc..

Clearance details

Applicant: Fibra Sonics, Inc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1981-12-03
Decision date: 1982-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.