KOI DIAMOND KNIFE— 510(k) K812450

Substantially Equivalent

Koi, Inc.

FDA 510(k) clearance K812450 for KOI DIAMOND KNIFE, Substantially Equivalent on 1981-09-21. Applicant: Koi, Inc..

Clearance details

Applicant: Koi, Inc.
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1981-08-28
Decision date: 1981-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code HNN

product code HNN

Injury: 183
Malfunction: 4,106
Total: 4,289

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.