CO2 PNEUMO-DISSECTOR— 510(k) K972647

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K972647 for CO2 PNEUMO-DISSECTOR, Substantially Equivalent on 1998-04-10. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1997-07-15
Decision date: 1998-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.