IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1— 510(k) K011965

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K011965 for IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1, Substantially Equivalent on 2001-07-13. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 2001-06-25
Decision date: 2001-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

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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.