BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET— 510(k) K033210

Substantially Equivalent

Bioteque Corp.

FDA 510(k) clearance K033210 for BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET, Substantially Equivalent on 2004-12-30. Applicant: Bioteque Corp..

Clearance details

Applicant: Bioteque Corp.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2003-10-03
Decision date: 2004-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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.