ENTRAC(TM) URETHRAL MEASURING CATHETER— 510(k) K914905

Substantially Equivalent

American Medical Systems, Inc.

FDA 510(k) clearance K914905 for ENTRAC(TM) URETHRAL MEASURING CATHETER, Substantially Equivalent on 1992-03-20. Applicant: American Medical Systems, Inc..

Clearance details

Applicant: American Medical Systems, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 1991-11-01
Decision date: 1992-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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.