CO2 PNEUMO-DISSECTOR— 510(k) K972647

Name: FDA 510(k) clearance K972647
Creator: U.S. Food and Drug Administration
Published: 1998-04-10

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K972647 for CO2 PNEUMO-DISSECTOR, Substantially Equivalent on 1998-04-10. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
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 ↗

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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.