510(k) K853403— STORZ DIAMOND KNIFE

Substantially Equivalent for Some Indications

Storz Instrument Co.

Clearance details

Applicant: Storz Instrument Co.
Product code: Code HNN
Advisory panel: Ophthalmic
Date received: 1985-08-12
Decision date: 1985-11-04
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: St. Louis, MO, 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.