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ControlSeal Electrode (ELSB)

by Coapt

510(k) K223605

ControlSeal Electrode (ELSB) is a medical device (FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Coapt, cleared under FDA 510(k) K223605 on 30 Dec 2022, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK223605 Date30 Dec 2022ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0204-2024 FDA Class II initiated 2 Oct 2023

    Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or warm temperatures for over 12 hours or battery is damaged.

Timeline

2 dated events

  1. Cleared FDA 510(k) K223605
  2. Recall initiated FDA recalls Z-0204-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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 K223605

5 devices · FDA GUDID

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.

Devices cleared under K223605
UDI-DISize and differences
ControlSeal Electrode Domes (Large Size) 1
Coapt, LLC
1B618E5 —On the market
ControlSeal Electrode Domes (Large Size) 1
Coapt, LLC
1B618E3 —On the market
ControlSeal Electrode Domes (Standard Size) 1
Coapt, LLC
1B618E2 —On the market
ControlSeal Electrode Domes (Standard Size) 1
Coapt, LLC
1B618E4 —On the market
ControlSeal Electrode Domes (Standard Size) 1
Coapt, LLC
1B618E1 —On the market

Similar devices

Other devices filed under FDA product code GXY (Electrode, Cutaneous).

Other devices from Coapt, LLC

See all devices from Coapt, LLC →