510(k) K850049— KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA

Substantially Equivalent

Xtal Corp.

Clearance details

Applicant: Xtal Corp.
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1985-01-08
Decision date: 1985-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malverne, PA, US

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.