UROLOGICAL CATHETER— 510(k) K992137

Substantially Equivalent

Apogee, Inc.

FDA 510(k) clearance K992137 for UROLOGICAL CATHETER, Substantially Equivalent on 1999-09-03. Applicant: Apogee, Inc..

Clearance details

Applicant: Apogee, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 1999-06-24
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, 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.