# ControlSeal Electrode (ELSB)

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/controlseal-electrode-elsb-gxy>
- Manufacturer: [Coapt](https://devicerts.com/manufacturers/coapt-llc) (United States)
- Device class: Class II (US FDA)
- FDA product code: GXY

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K223605 · decision 2022-12-30 · decision SESE · status: Active

## Recalls

- Z-0204-2024 · Class II · ongoing · initiated 2023-10-02: 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.

## Identifiers

- 510(k) Number: K223605 [FDA 510(k)]
- FDA product code: GXY [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 882.1320 [FDA 510(k)]
- Advisory committee: Neurology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: ControlSeal Electrode (ELSB), Coapt. deviCERTS medical device catalogue. https://devicerts.com/devices/controlseal-electrode-elsb-gxy (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/controlseal-electrode-elsb-gxy.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/controlseal-electrode-elsb-gxy
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.