HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE— 510(k) K861904

Substantially Equivalent

Cooper Lasersonics, Inc.

FDA 510(k) clearance K861904 for HS-15M MICROWAVE SURGERY EQUIPMENT, MICROTAZE, Substantially Equivalent on 1986-10-16. Applicant: Cooper Lasersonics, Inc..

Clearance details

Applicant: Cooper Lasersonics, Inc.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 1986-05-16
Decision date: 1986-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

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.