UNIPUNCTURE CATHETER— 510(k) K791490

Substantially Equivalent

Hospal Medical Corp.

FDA 510(k) clearance K791490 for UNIPUNCTURE CATHETER, Substantially Equivalent on 1979-10-26. Applicant: Hospal Medical Corp..

Clearance details

Applicant: Hospal Medical Corp.
Product code: Code FIE
Advisory panel: Gastroenterology, Urology
Date received: 1979-08-03
Decision date: 1979-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FIE

product code FIE

Death: 2
Total: 2

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.