Max-25
by CLASSYS Inc.
Max-25 is a Class II device made by CLASSYS Inc., cleared under FDA 510(k) K241157 on 21 Nov 2024 and listed in FDA GUDID since 2 Jul 2025 (UDI-DI 08800016903140), active as of 21 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 | Number08800016903140 | Date2 Jul 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241157 | Date21 Nov 2024 | StatusActive |
Official records
- AccessGUDID record 08800016903140
- FDA 510(k) database K241157
Across registries
- FDA 510(k) K241157 decided 21 Nov 2024 Active
- FDA GUDID UDI-DI 08800016903140 listed 2 Jul 2025 Listed
Timeline
- Cleared FDA 510(k) K241157
- Listed FDA GUDID 08800016903140
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Open-surgery electrosurgical electrode, monopolar, single-use
- Model / reference
- MAX-25
- Primary DI / UDI-DI
- 08800016903140
- 510(k) Number
- FDA product code
- OUH
- GMDN term
- Open-surgery electrosurgical electrode, monopolar, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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