DISPOSABLE VITRECTOMY HANDPIECE— 510(k) K832235

Substantially Equivalent

Innovative Surgical Products, Inc.

FDA 510(k) clearance K832235 for DISPOSABLE VITRECTOMY HANDPIECE, Substantially Equivalent on 1983-09-29. Applicant: Innovative Surgical Products, Inc..

Clearance details

Applicant: Innovative Surgical Products, Inc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1983-07-11
Decision date: 1983-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.