VenaCure EVLT 11403004
VenaCure EVLT 11403004 is a Class II device made by Angiodynamics, Inc., cleared under FDA 510(k) K231945 on 20 Jul 2023 (3 earlier submissions) and listed in FDA GUDID since 20 Sep 2016 (UDI-DI H787114030040), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231945 | Date20 Jul 2023 | StatusActive |
| United States | GUDID listing | NumberH787114030040 | Date20 Sep 2016 | StatusListed |
Official records
- FDA 510(k) database K231945
- FDA 510(k) database K171921
- FDA 510(k) database K162914
- FDA 510(k) database K112600
Across registries
- FDA 510(k) K231945 decided 20 Jul 2023 Active
- FDA GUDID UDI-DI H787114030040 listed 20 Sep 2016 Listed
Recalls
-
- Terminated Z-2444-2019
The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID programmed expiration date is April-2014 which results in an error message when connected to the laser source and prevents the product from being used.
Timeline
- Cleared FDA 510(k) K112600
- Listed FDA GUDID H787114030040
- Cleared FDA 510(k) K162914
- Cleared FDA 510(k) K171921
- Recall initiated FDA recalls Z-2444-2019
- Cleared FDA 510(k) K231945
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VenaCure EVLT
- Generic name
- Varicose vein lasing procedure kit
- Model / reference
- 11403004
- Primary DI / UDI-DI
- H787114030040
- FDA product code
- GEX
- GMDN term
- Varicose vein lasing procedure kit
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 90 CentimeterNeedle Gauge — 21 Gauge
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