Konmed Km-505
by Shenzhen Konmed Technology Co., Ltd.
Konmed Km-505 is a Class II device made by Shenzhen Konmed Technology Co., Ltd., cleared under FDA 510(k) K233576 on 23 Feb 2024 and listed in FDA GUDID since 5 Mar 2024 (UDI-DI 06970935830659), 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 | GUDID listing | Number06970935830659 | Date5 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233576 | Date23 Feb 2024 | StatusActive |
Official records
- AccessGUDID record 06970935830659
- FDA 510(k) database K233576
Across registries
- FDA 510(k) K233576 decided 23 Feb 2024 Active
- FDA GUDID UDI-DI 06970935830659 listed 5 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K233576
- Listed FDA GUDID 06970935830659
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Konmed
- Generic name
- Perineal orifice incontinence-control electrical stimulation system probe, reusable
- Model / reference
- KM-505
- Primary DI / UDI-DI
- 06970935830659
- 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
- MRI safety
- MR Unsafe
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