Identity
- Trade Name
- FIT EUDAMEDFDA UDI
- Generic Name
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
- Device Name
- Accessories for Endoscopy EUDAMEDFIT Biliary Stone Balloon Long Wire FDA UDIFIT Biliary Stone Balloon Short Wire FDA UDI
- Model / Reference
- F922SW EUDAMEDFDA UDIF922LW FDA UDI
- Description
- FIT Biliary Stone Balloon Long Wire FDA UDIFIT Biliary Stone Balloon Short Wire FDA UDI
Identifiers
- Catalog Number
- F922LW FDA UDIF922SW FDA UDI
- Primary DI / UDI-DI
- 10653405006404 EUDAMEDFDA UDI10653405006411 FDA UDI
- Basic UDI-DI
- B-10653405006404 EUDAMED
- 510(k) Number
- K131642 FDA UDI
- FDA Product Code
- FGE FDA UDI
- EMDN Code
- G03010199 GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER EUDAMED
- GMDN Term
- ERCP catheter, balloon, non-electrical, stone-retrieval FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.035 Inch FDA UDIOuter Diameter — 0.89 Millimeter FDA UDI
Category: ERCP catheter, balloon, non-electrical, stone-retrieval
Fit by Conmed Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as ERCP catheter, balloon, non-electrical, stone-retrieval.
- Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Anrei — Anrei Medical(HZ) Co., Ltd. · Class II
- Sterile Biliary Stone Retrieval Balloon Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Single Use Balloon Dilator V (with knife) — Olympus Medical Systems Corporation · Class II
- Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Single Use 3-Lumen Extraction Balloon V — Olympus Medical Systems Corporation · Class II
- Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Retrieval Balloon short-wire compatible — Micro-Tech (Nanjing) Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (3)
- FDA UDI d04eb003-98da-416e-922d-22ab660df2b4 37 fields · synced Aug 1, 2026
- FDA UDI 61df226b-3243-4413-8506-d21a66d080d0 37 fields · synced May 30, 2026
- EUDAMED f6744419-c1be-40dc-90c7-e7c134250862 61 fields · synced Aug 1, 2026