KRUPIN EYE VALVE W/SCLERAL BUCKLE— 510(k) K885125

Substantially Equivalent

Hood Laboratories

FDA 510(k) clearance K885125 for KRUPIN EYE VALVE W/SCLERAL BUCKLE, Substantially Equivalent on 1989-01-24. Applicant: Hood Laboratories.

Clearance details

Applicant: Hood Laboratories
Product code: Code KYF
Advisory panel: Ophthalmic
Date received: 1988-12-12
Decision date: 1989-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pembroke, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYF

product code KYF

Injury: 1,543
Malfunction: 646
Total: 2,189

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.