RSE1000
RSE1000 is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K850108 on 11 Apr 1985 and listed in FDA GUDID since 5 May 2016 (UDI-DI 00613994870919), active as of 8 Nov 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 | Number00613994870919 | Date5 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK850108 | Date11 Apr 1985 | StatusActive |
Official records
- AccessGUDID record 00613994870919
- FDA 510(k) database K850108
Across registries
- FDA 510(k) K850108 decided 11 Apr 1985 Active
- FDA GUDID UDI-DI 00613994870919 listed 5 May 2016 Listed
Timeline
- Cleared FDA 510(k) K850108
- Listed FDA GUDID 00613994870919
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nerve-locating system
- Model / reference
- RSE1000
- Primary DI / UDI-DI
- 00613994870919
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Nerve-locating system
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code GXY (ELECTRODE, CUTANEOUS).
- AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE by Ambu, Inc.
- NEUROLINK EEG/EP/EMG SURFACE ELECTRODES by Neuro Supplies, Inc.
- AUTOMATIC ELECTRODE PLACEMENT BELT by Wallant Intl. Trade, Inc.
- TENS CONDUCTIVE MEDIA PAD by Alternative Design Systems, Inc.
- Conductive Silicone Rubber Electrode by Guangzhou Xinbo Electronic Co.,Ltd
- CARBON ELECTRODE by Futuremed Div. of Future Impex Corp.
- Starly pad by Shenzhen Xingyuanli Technology Co., Ltd
- TENSAGAIN by Ferris Mfg. Corp.
- ELECTRODES, STAODERM STERILE by Staodynamics, Inc.
- Dexus Prosthetic System (MSL2) by Zhejiang Qiangnao Technology Co., Ltd