IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP— 510(k) K102527

Clearance details

Device name as filed

IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER

Applicant

Boston Scientific Corporation

Product code

Code KOD

Device class

Class 2

Regulation

21 CFR 876.5130

Advisory panel

Gastroenterology, Urology

Date received

2010-09-02

Decision date

2010-11-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Marlboro, MA, US

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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 →