Autotome Pro RX 39 Sphincterotome +6 more— 510(k) K232162

Clearance details

Device name as filed

Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome

Applicant

Boston Scientific Corporation

Product code

Code KNS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2023-07-21

Decision date

2023-08-14

Decision

Substantially Equivalent

Clearance type

Special

Location

Marlboro, MA, US

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Death

44

Injury

2,361

Malfunction

4,771

Total

7,176

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 →