VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG— 510(k) K791212

Substantially Equivalent

Precision Medical Instruments, Inc.

FDA 510(k) clearance K791212 for VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG, Substantially Equivalent on 1979-08-10. Applicant: Precision Medical Instruments, Inc..

Clearance details

Applicant: Precision Medical Instruments, Inc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1979-07-03
Decision date: 1979-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.