PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM— 510(k) K862021

Substantially Equivalent

Ultramed, Inc.

FDA 510(k) clearance K862021 for PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM, Substantially Equivalent on 1986-06-23. Applicant: Ultramed, Inc..

Clearance details

Applicant: Ultramed, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 1986-05-28
Decision date: 1986-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, CA, US

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Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

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.