SURGITEK NEPHROSTENT KIT— 510(k) K831446

Substantially Equivalent

Mec/Surgitek Products

FDA 510(k) clearance K831446 for SURGITEK NEPHROSTENT KIT, Substantially Equivalent on 1983-06-22. Applicant: Mec/Surgitek Products.

Clearance details

Applicant: Mec/Surgitek Products
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1983-05-05
Decision date: 1983-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.