Model 3854 Electrode
510(k) K820876
Model 3854 Electrode is a Class II device made by Medtronic Vascular, cleared under FDA 510(k) K820876 on 21 Apr 1982, 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 | NumberK820876 | Date21 Apr 1982 | StatusActive |
Official records
- FDA 510(k) database K820876
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- Withdrawn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
Similar devices
Other devices filed under FDA product code GXY (Electrode, Cutaneous).
- XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES by Excel Tech., Ltd.
- Alpha Control Liner System (ACLS) by Coapt, LLC
- DIGITAL RING ELECTRDE by Neuro Supplies, Inc.
- DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS by La Jolla Technology, Inc.
- GROUND PLATE ELECTRODE by Cadwell Laboratories, Inc.
- FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 by Enraf-Nonius B.V.
- EMG DISC RECORDING ELECTRODE WITH PIN by Chalgren Enterprises, Inc.
- Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) by Guangzhou Xinbo Electronic Co.,Ltd
- VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART by Conmedcorp
- PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535 by Medical Devices, Inc.