AUTOCATH(TM) SET— 510(k) K910876

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K910876 for AUTOCATH(TM) SET, Substantially Equivalent on 1991-05-28. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 1991-03-01
Decision date: 1991-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

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Adverse events under product code GBM

product code GBM

Injury: 397
Malfunction: 1,404
Total: 1,801

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.