TubeClear NE-1036
TubeClear NE-1036 is a Class II device made by Actuated Medical, Inc., cleared under FDA 510(k) K172556 on 29 Jun 2018 (1 earlier submission) and listed in FDA GUDID since 27 Oct 2016 (UDI-DI 00850458007362), 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 | FDA 510(k)SESE | NumberK172556 | Date29 Jun 2018 | StatusActive |
| United States | GUDID listing | Number00850458007362 | Date27 Oct 2016 | StatusListed |
Official records
- AccessGUDID record 00850458007362
- FDA 510(k) database K172556
- FDA 510(k) database K131052
Across registries
- FDA 510(k) K172556 decided 29 Jun 2018 Active
- FDA GUDID UDI-DI 00850458007362 listed 27 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K131052
- Listed FDA GUDID 00850458007362
- Cleared FDA 510(k) K172556
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- TubeClear
- Generic name
- Enteral feeding/decompression tube clearing stem
- Model / reference
- NE-1036
- Primary DI / UDI-DI
- 00850458007362
- FDA product code
- FPD, KNT
- GMDN term
- Enteral feeding/decompression tube clearing stem
- Device class
- Class II
- Regulation number
- 876.5980
- GUDID distribution status
- In Commercial Distribution
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