Sentio 286240500
Sentio 286240500 is a Class II device made by Medos International Sàrl, cleared under FDA 510(k) K173526 on 5 Apr 2018 and listed in FDA GUDID since 8 Oct 2018 (UDI-DI 10705034534923), 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 | Number10705034534923 | Date8 Oct 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173526 | Date5 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 10705034534923
- FDA 510(k) database K173526
Across registries
- FDA 510(k) K173526 decided 5 Apr 2018 Active
- FDA GUDID UDI-DI 10705034534923 listed 8 Oct 2018 Listed
Timeline
- Cleared FDA 510(k) K173526
- Listed FDA GUDID 10705034534923
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sentio
- Generic name
- Nerve-locating system
- Model / Ref / Catalog
- 286240500
- Primary DI / UDI-DI
- 10705034534923
- 510(k) Number
- FDA product code
- PDQ, ETN
- GMDN term
- Nerve-locating system
- Device class
- Class II
- Regulation number
- 874.1820
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code PDQ (Neurosurgical nerve locator).
- NUVASIVE EMG ENDOTRACHEAL TUBE by Nu Vasive, Incorporated
- Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) by TeDan Surgical Innovations, Inc.
- PHANTOM XL INSULATED DILATORS by TeDan Surgical Innovations, Inc.
- BE-ST NIM PAK Needle Bevel PK1006 by Lacey Manufacturing Company, LLC
- CADWELL DISPOSABLE PROBE HANDLE by Cadwell
- NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe by Boston Endo Surgical Tech,
- NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE by Neurovision Medical Product, Inc.
- ATEC IOM Accessory Instruments by ALPHATEC SPINE, INC.
- Cadwell Guardian 190311-200 by Cadwell Industries, Inc.
- Boston Endo Surgical Technologies LLC PK1012 by Lacey Manufacturing Company, LLC