vTone Tip AG608643A
vTone Tip AG608643A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K200293 on 5 May 2020 and listed in FDA GUDID since 27 Oct 2022 (UDI-DI 07290016633597), 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 | Number07290016633597 | Date27 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200293 | Date5 May 2020 | StatusActive |
Official records
- AccessGUDID record 07290016633597
- FDA 510(k) database K200293
Across registries
- FDA 510(k) K200293 decided 5 May 2020 Active
- FDA GUDID UDI-DI 07290016633597 listed 27 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K200293
- Listed FDA GUDID 07290016633597
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- vTone Tip
- Generic name
- Perineal orifice incontinence-control electrical stimulation system probe, reusable
- Model / Ref / Catalog
- AG608643A
- Primary DI / UDI-DI
- 07290016633597
- 510(k) Number
- FDA product code
- KPI
- GMDN term
- Perineal orifice incontinence-control electrical stimulation system probe, reusable
- Device class
- Class II
- Regulation number
- 876.5320
- GUDID distribution status
- In Commercial Distribution
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