PNEUMATIC VITRECTOMY CONTROL UNIT— 510(k) K781471

Substantially Equivalent

Helfgott Medical Instruments

FDA 510(k) clearance K781471 for PNEUMATIC VITRECTOMY CONTROL UNIT, Substantially Equivalent on 1978-11-08. Applicant: Helfgott Medical Instruments.

Clearance details

Applicant: Helfgott Medical Instruments
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1978-08-28
Decision date: 1978-11-08
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.