Consulting Wallah › Device Explorer › Catheters & tubes › ERCP catheter, non-balloon, electrosurgical
Device Explorer · FDA GUDID · GMDN 65185

ERCP catheter, non-balloon, electrosurgical

A flexible, tubular device designed to be inserted into the duodenum via the oral cavity (cannulation) using a flexible endoscope to: 1) infuse contrast media; and 2) deliver electrosurgical current in a monopolar configuration to cut the major duodenal papill

US‑registered devices123in commercial distribution
Companies2labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription41%Rx‑only share
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Share of device records

Beijing Zksk Technology Co.,Ltd7259%
Boston Scientific Corporation5141%

Top labelers

CompanyDevicesShare
Beijing Zksk Technology Co.,Ltd7259%
Boston Scientific Corporation5141%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ZKSKJagtome™ Revolution Pro RX 39Jagtome™ Pro RX 39Jagtome™ Pro RX 44Hydratome™ Pro RX 44Dreamtome™ Pro RX 44Autotome™ Pro RX 39Autotome™ Pro RX 44Jagtome™ Revolution RXDreamtome™ RX 44Dreamtome™ RX 49Jagtome RX 44Jagtome RX 39Hydratome RX 44Hydratome RX 49Autotome™ RX 39

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessori72
KNSUnit, electrosurgical, endoscopic (with or without accessori51
FDISNARE, FLEXIBLE8

GMDN & GCC registration

  • GMDN code 65185 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 41% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many ercp catheter, non-balloon, electrosurgical products are registered in the US?

123 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "ERCP catheter, non-balloon, electrosurgical", from 2 companies. The largest labeler is Beijing Zksk Technology Co.,Ltd with 59% of records.

Which FDA product codes apply?

KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessori), KNS (Unit, electrosurgical, endoscopic (with or without accessori), FDI (SNARE, FLEXIBLE)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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