Disposable Snap Electrode
510(k) K172703
Disposable Snap Electrode is a Class II device made by Embla Systems, cleared under FDA 510(k) K172703 on 13 Nov 2017, 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 | NumberK172703 | Date13 Nov 2017 | StatusActive |
Official records
- FDA 510(k) database K172703
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GXY
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K172703
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Natus 1410500 | 1410500 | 00382830025263 | On the market | |
| Natus 1411516 | 1411516 | 00382830025331 | On the market | |
| Natus 1411520 | 1411520 | 00382830053938 | On the market |
Similar devices
Other devices filed under FDA product code GXY (Electrode, Cutaneous).
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- TENSAGAIN by Ferris Mfg. Corp.
- ELECTRODES, STAODERM STERILE by Staodynamics, Inc.
- Dexus Prosthetic System (MSL2) by Zhejiang Qiangnao Technology Co., Ltd
- BIS 186-0212 by Covidien LP
- PALS PLATINUM NEUROSTIMULATION ELECTRODES by AXELGAARD MFG. CO., LTD.
- THERMOSKIN CONDUCTIVE PADS by United Pacific Co., Ltd.