H-H SEXTON SCUP URINE MGMT. SYS— 510(k) K853458

Substantially Equivalent

Holter-Hausner Intl.

FDA 510(k) clearance K853458 for H-H SEXTON SCUP URINE MGMT. SYS, Substantially Equivalent on 1985-08-27. Applicant: Holter-Hausner Intl..

Clearance details

Applicant: Holter-Hausner Intl.
Product code: Code KNX
Advisory panel: Gastroenterology, Urology
Date received: 1985-08-16
Decision date: 1985-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, PA, US

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Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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.