HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP— 510(k) K945764

Substantially Equivalent

Aaron Medical Industries

FDA 510(k) clearance K945764 for HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP, Substantially Equivalent on 1995-01-30. Applicant: Aaron Medical Industries.

Clearance details

Applicant: Aaron Medical Industries
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 1994-11-01
Decision date: 1995-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

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Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.