Consulting Wallah › Device Explorer › Catheters & tubes › ERCP catheter, balloon, non-electrical, stone-retr
Device Explorer · FDA GUDID · GMDN 46715

ERCP catheter, balloon, non-electrical, stone-retrieval

A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the wo

US‑registered devices206in commercial distribution
Companies11labelers on GUDID
Single‑use97%of device records
Sterile97%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Micro-Tech (Nanjing) Co., Ltd.7034%
Zhejiang Chuangxiang Medical Technology Co., Ltd.4220%
Hangzhou Ags Medtech Co., Ltd.2412%
Cook Incorporated189%
Boston Scientific Corporation189%
Olympus Medical Systems Corp.136%
Conmed Corporation84%
Smith & Nephew, Inc.63%

Top labelers

CompanyDevicesShare
Micro-Tech (Nanjing) Co., Ltd.7034%
Zhejiang Chuangxiang Medical Technology Co., Ltd.4220%
Hangzhou Ags Medtech Co., Ltd.2412%
Cook Incorporated189%
Boston Scientific Corporation189%
Olympus Medical Systems Corp.136%
Conmed Corporation84%
Smith & Nephew, Inc.63%
Telemed Systems42%
Anrei Medical(Hz) Co.,Ltd.21%
Jiangsu Vedkang Medical Science And Technology Co.,Ltd.10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Single use stone retrieval balloonsStone Extraction BalloonNAAnreiRetrieval Balloon short-wire compatibleSterile Biliary Stone Retrieval Balloon CatheterSingle Use Balloon Dilator V (with knife)Single Use 3-Lumen Extraction Balloon VEVOSTri-ExFusion QuattroFusionEscort IIDisposable Duralon Occlusion Balloon - 2 LumenDURAGLIDEFIT

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

FDA product codes

CodeNameDevices
FGEStents, Drains And Dilators For The Biliary Ducts116
FGECATHETER, BILIARY, DIAGNOSTIC47
GCACATHETER, BILIARY, SURGICAL32
GCABiliary Catheter For Stone Removal That May Also Allow For I27
LQRDISLODGER, STONE, BILIARY16
FGEStents, drains and dilators for the biliary ducts9

GMDN & GCC registration

  • GMDN code 46715 · non‑implantable
  • Single‑use 97% · sterile 97% · Rx‑only 97% · 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

Catheter Working Length (Millimeter) · 70Balloon Diameter (Millimeter) · 68Outer Diameter (Millimeter) · 14Outer Diameter (Inch) · 2

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

How many ercp catheter, balloon, non-electrical, stone-retrieval products are registered in the US?

206 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "ERCP catheter, balloon, non-electrical, stone-retrieval", from 11 companies. The largest labeler is Micro-Tech (Nanjing) Co., Ltd. with 34% of records.

Which FDA product codes apply?

FGE (Stents, Drains And Dilators For The Biliary Ducts), FGE (CATHETER, BILIARY, DIAGNOSTIC), GCA (CATHETER, BILIARY, SURGICAL), GCA (Biliary Catheter For Stone Removal That May Also Allow For I)

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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