MOLTENO VALVE SETON— 510(k) K875099

Substantially Equivalent

Staar Surgical Co.

FDA 510(k) clearance K875099 for MOLTENO VALVE SETON, Substantially Equivalent on 1988-03-30. Applicant: Staar Surgical Co..

Clearance details

Applicant: Staar Surgical Co.
Product code: Code KYF
Advisory panel: Ophthalmic
Date received: 1987-12-10
Decision date: 1988-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monrovia, CA, US

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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.