neXus 100-25-0001
by Misonix, LLC
neXus 100-25-0001 is a device classified as Unclassified made by Misonix, LLC, cleared under FDA 510(k) K190160 on 30 May 2019 and listed in FDA GUDID since 24 Feb 2020 (UDI-DI 00841626102545), 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 | Number00841626102545 | Date24 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190160 | Date30 May 2019 | StatusActive |
Official records
- AccessGUDID record 00841626102545
- FDA 510(k) database K190160
Across registries
- FDA 510(k) K190160 decided 30 May 2019 Active
- FDA GUDID UDI-DI 00841626102545 listed 24 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K190160
- Listed FDA GUDID 00841626102545
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- neXus
- Generic name
- Soft-tissue ultrasonic surgical system handpiece, reusable
- Model / reference
- 100-25-0001
- Primary DI / UDI-DI
- 00841626102545
- 510(k) Number
- FDA product code
- LFL, GEI
- GMDN term
- Soft-tissue ultrasonic surgical system handpiece, reusable
- Device class
- U
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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