PALA-NATE Small
by Utah Medical Products, Inc.
PALA-NATE Small (4002000) is a Class II device made by Utah Medical Products, Inc., cleared under FDA 510(k) K923591 on 16 Mar 1993 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI H67140020000), 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 | NumberH67140020000 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK923591 | Date16 Mar 1993 | StatusActive |
Official records
- FDA 510(k) database K923591
Across registries
- FDA 510(k) K923591 decided 16 Mar 1993 Active
- FDA GUDID UDI-DI H67140020000 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K923591
- Listed FDA GUDID H67140020000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pala-Nate
- Generic name
- Endotracheal tube holder
- Model / Ref / Catalog
- Small, 4002000
- Primary DI / UDI-DI
- H67140020000
- 510(k) Number
- FDA product code
- BTR
- GMDN term
- Endotracheal tube holder
- Device class
- Class II
- Regulation number
- 868.5730
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 1.8 CentimeterWidth — 2 Centimeter
Similar devices in this category
Other devices filed under Endotracheal tube holder.