Identity
- Trade Name
- Lumiflex FDA UDI
- Generic Name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
- Device Name
- LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm wire is made of nylon and is a progressive stage balloon capable of three disctinct and progressively larger diameters via controlled radial expansion. FDA UDI
- Model / Reference
- 00715518W FDA UDI
- Description
- LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm wire is made of nylon and is a progressive stage balloon capable of three disctinct and progressively larger diameters via controlled radial expansion. FDA UDI
Identifiers
- Catalog Number
- 00715518W FDA UDI
- Primary DI / UDI-DI
- 00724995244590 FDA UDI
- 510(k) Number
- K241888 FDA UDI
- FDA Product Code
- KNQ FDA UDIFGE FDA UDI
- GMDN Term
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5365 FDA UDI876.5010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Guidewire Diameter — 0.89 Millimeter FDA UDIBalloon Length — 5.5 Centimeter FDA UDICatheter Length — 240 Centimeter FDA UDI
Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated
Lumiflex by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Flex-Ez Stylet Wire Balloon Dilator — HOBBS MEDICAL, INC. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Reliant(TM) Multistage Dilatation Balloon Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class II
- MaxForce TTS — Boston Scientific · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- US Endoscopy
Sources (1)
- FDA UDI 9ae5b196-8276-45d1-b52f-07073cfa8e43 38 fields · synced May 30, 2026