AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE— 510(k) K860891

Substantially Equivalent

Intra-Optics Labs. C/O Newman Assoc.

FDA 510(k) clearance K860891 for AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE, Substantially Equivalent on 1986-04-21. Applicant: Intra-Optics Labs. C/O Newman Assoc..

Clearance details

Applicant: Intra-Optics Labs. C/O Newman Assoc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1986-03-10
Decision date: 1986-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, 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.