SURGITEK INFUSER— 510(k) K941952

Substantially Equivalent

Surgitek

FDA 510(k) clearance K941952 for SURGITEK INFUSER, Substantially Equivalent on 1994-05-24. Applicant: Surgitek.

Clearance details

Applicant: Surgitek
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1994-04-22
Decision date: 1994-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

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Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.