VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,— 510(k) K090960

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K090960 for VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,, Substantially Equivalent on 2009-08-20. Applicant: Hollister, Inc..

Clearance details

Applicant: Hollister, Inc.
Product code: Code GBM
Advisory panel: Gastroenterology, Urology
Date received: 2009-04-06
Decision date: 2009-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, 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.