URETERAL ACCESS SHEATH SET (UASS)— 510(k) K022135

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K022135 for URETERAL ACCESS SHEATH SET (UASS), Substantially Equivalent on 2002-09-13. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 2002-07-01
Decision date: 2002-09-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.