Lumiflex 00718008W
by US Endoscopy
Lumiflex 00718008W is a Class II device made by US Endoscopy, cleared under FDA 510(k) K241888 on 20 Dec 2024 and listed in FDA GUDID since 3 Jun 2025 (UDI-DI 00724995244675), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00724995244675 | Date3 Jun 2025 | StatusListed |
| United States | FDA 510(k) | NumberK241888 | Date20 Dec 2024 | StatusActive |
Official records
- AccessGUDID record 00724995244675
- FDA 510(k) database K241888
Across registries
- FDA 510(k) K241888 decided 20 Dec 2024 Active
- FDA GUDID UDI-DI 00724995244675 listed 3 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K241888
- Listed FDA GUDID 00724995244675
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lumiflex
- Generic name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated
- Model / Ref / Catalog
- 00718008W
- Primary DI / UDI-DI
- 00724995244675
- 510(k) Number
- FDA product code
- KNQ, FGE
- GMDN term
- Gastrointestinal/biliary dilation balloon catheter, non-medicated
- Device class
- Class II
- Regulation number
- 876.5365, 876.5010
- GUDID distribution status
- In Commercial Distribution
- Size
- Catheter Length — 180 CentimeterBalloon Length — 8 CentimeterGuidewire Diameter — 0.89 Millimeter
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