COOK ASPIRATION/IRRIGATION UNIT— 510(k) K944818

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K944818 for COOK ASPIRATION/IRRIGATION UNIT, Substantially Equivalent on 1994-11-08. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1994-09-29
Decision date: 1994-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.