LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35— 510(k) K860822

Substantially Equivalent

Cooper Lasersonics, Inc.

FDA 510(k) clearance K860822 for LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35, Substantially Equivalent on 1986-04-17. Applicant: Cooper Lasersonics, Inc..

Clearance details

Applicant: Cooper Lasersonics, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 1986-03-04
Decision date: 1986-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.