Venacure 1470 Pro
510(k) K181632
Venacure 1470 Pro is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K181632 on 17 Sep 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181632 | Date17 Sep 2018 | StatusActive |
Official records
- FDA 510(k) database K181632
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K181632
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VenaCure 1470 Pro PDMS00252 | H787VC1470PRO / PDMS00252 | 08033945938925 | — | On the market |
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