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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

by Boston Scientific

510(k) K232162

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232162↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK232162 Date14 Aug 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
KNS
Models / Variants
FDA applicant
Boston Scientific Corporation
Device Class
Class II
Regulation
21 CFR Part 876.4300
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Autotome Pro and Jagtome Revolution Pro RX Sphincterotomes are electrosurgical, endoscopic devices designed for cutting and coagulating tissue. These devices fall under the category of endoscopic units with accessories, specifically intended for sphincterotomy procedures in gastroenterology and urology. Their primary function is to incise the sphincter of Oddi or other anatomical sphincters during endoscopic retrograde cholangiopancreatography (ERCP) or similar interventions.

These devices are supplied as single-use, sterile instruments and are intended for use in controlled clinical settings such as operating rooms or endoscopy suites. They are classified under device class II and comply with FDA 510(k) clearance and EU MDR regulations. The RX 39 and RX 44 designations refer to specific blade sizes, ensuring compatibility with various anatomical requirements. Proper storage and handling per manufacturer instructions are required to maintain sterility and functionality.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the key differences between the RX 39 and RX 44 blade sizes in these sphincterotomes, and how might they impact clinical use?

    The RX 39 and RX 44 designations refer to specific blade sizes tailored to different anatomical requirements. The RX 39 is designed for smaller or more delicate sphincterotomies, while the RX 44 offers a slightly larger cutting surface, which may be preferred for broader or more robust tissue incisions. These variations allow clinicians to select the appropriate blade size based on patient anatomy and procedural needs, ensuring precision during sphincterotomy in ERCP or similar interventions.

  • Are these sphincterotomes reusable, or are they intended for single-use only? How does this affect their storage and handling?

    These devices are explicitly supplied as single-use, sterile instruments. As such, they must be stored according to the manufacturer’s instructions to maintain sterility and functionality. Single-use design eliminates the need for reprocessing, reducing the risk of contamination or damage between procedures, and ensures consistent performance in controlled clinical settings like endoscopy suites or operating rooms.

  • What regulatory pathways have these sphincterotomes undergone, and how does this affect their use in clinical practice?

    These devices are cleared under FDA 510(k) and comply with EU MDR (Medical Device Regulation). The clearance type is classified as Special, with a decision code of *SESE* (Substantially Equivalent), indicating they meet FDA standards for safety and effectiveness. Clinically, this means they are approved for use in gastroenterology and urology procedures involving sphincterotomy, such as ERCP, and can be trusted for their intended electrosurgical functions in regulated healthcare environments.

  • Which models in this lineup are part of the Jagtome or Dreamtome series, and how do they differ from the Autotome Pro line?

    The Jagtome Pro series includes the *Jagtome Pro RX 39*, *Jagtome Pro RX 44*, and *Jagtome Revolution Pro RX 39*, while the Dreamtome Pro series features the *Dreamtome Pro RX 44*. The Autotome Pro line consists of the *Autotome Pro RX 39* and *Autotome Pro RX 44*. While all are electrosurgical sphincterotomes designed for cutting and coagulating tissue during ERCP or similar procedures, the Jagtome Revolution Pro may incorporate updated or refined technology compared to earlier models, though the core function remains consistent across the series.