KOI LACRIMAL INTUBATION SYSTEM— 510(k) K812010

Substantially Equivalent

Koi, Inc.

FDA 510(k) clearance K812010 for KOI LACRIMAL INTUBATION SYSTEM, Substantially Equivalent on 1981-07-28. Applicant: Koi, Inc..

Clearance details

Applicant: Koi, Inc.
Product code: Code HMX
Advisory panel: Ophthalmic
Date received: 1981-07-17
Decision date: 1981-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HMX

product code HMX

Other: 1
Total: 1

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.