ControlSeal Electrode (ELSB)
FDA 510(k) clearance K223605 · decided 2022-12-30
Clearance details
- K-number
- K223605
- Device name
- ControlSeal Electrode (ELSB)
- Applicant
- Coapt
- Decision
- Substantially Equivalent
- Date received
- 2022-12-02
- Decision date
- 2022-12-30
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- GXY
- Device class
- 2
- Regulation number
- 882.1320
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Coapt ControlSeal Electrode, cutaneous EMG Electrode recall (Z-0204-2024) | Coapt LLC | 2023-10-31 |