Elec-Tip
510(k) K873298
Elec-Tip is a medical device (FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Etymotic Research, cleared under FDA 510(k) K873298 on 24 Nov 1987, 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 | NumberK873298 | Date24 Nov 1987 | StatusActive |
Official records
- FDA 510(k) database K873298
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- Withdrawn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 K873298
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 | |||
|---|---|---|---|---|
| Etymotic Research ER3-04B | ER3-04B | 00846430004818 | On the market | |
| Etymotic Research ER3-26A | ER3-26A | 00846430004047 | Outer Diameter 13 mm | On the market |
| Etymotic Research ER3-26B | ER3-26B | 00846430004061 | Outer Diameter 10 mm | On the market |
| Etymotic Research ER3-28S | ER3-28S | 00846430005372 | On the market |
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Other devices filed under FDA product code GXY (Electrode, Cutaneous).
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- Ultra-Garment Electrode by Newwave Medical, LLC
- Disposable Adhesive Surface Electrodes, Disc Electrodes by Technomed Europe
- Comfort-Ease Electrode by MEDTRONIC VASCULAR, INC.
- KM-10 TENS Electrode by KATECHO LLC