Avanos 39253
Avanos 39253 (ES500) is a Class II device made by Avanos Medical, Inc., cleared under FDA 510(k) K162048 on 5 Dec 2016 and listed in FDA GUDID since 7 May 2020 (UDI-DI 00193494392536), 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 | Number00193494392536 | Date7 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162048 | Date5 Dec 2016 | StatusActive |
Official records
- AccessGUDID record 00193494392536
- FDA 510(k) database K162048
Across registries
- FDA 510(k) K162048 decided 5 Dec 2016 Active
- FDA GUDID UDI-DI 00193494392536 listed 7 May 2020 Listed
Timeline
- Cleared FDA 510(k) K162048
- Listed FDA GUDID 00193494392536
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Avanos
- Generic name
- Nerve-locating system
- Model / Ref / Catalog
- 39253, ES500
- Primary DI / UDI-DI
- 00193494392536
- 510(k) Number
- FDA product code
- KOI
- GMDN term
- Nerve-locating system
- Device class
- Class II
- Regulation number
- 868.2775
- GUDID distribution status
- In Commercial Distribution
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