Data / Medical devices / United States / Coapt LLC
Coapt LLC: FDA-registered device maker in Chicago, IL, United States, 2 510(k) clearances
Coapt LLC is registered with the FDA (registration 3010605876) in Chicago, IL, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 30, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010605876
- Address
- 303 W. Institute Pl. Suite 200, Chicago, IL, United States, 60610
- Owner or operator
- Coapt, LLC (10045459)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer
- First device listed
- May 28, 2019
- Registered through
- 2026
- Brand names listed
- COMPLETE CONTROL System Gen2, Coapt Evaluation Kit, ControlSeal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Prosthesis Alignment | IQO | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Hand, External Limb Component, Powered | IQZ | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 30, 2022 | K223605 | ControlSeal Electrode (ELSB) | GXY | Substantially Equivalent | Coapt | accessdata.fda.gov |
| May 24, 2019 | K191083 | COMPLETE CONTROL System Gen2 | GXY | Substantially Equivalent | Coapt, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 2, 2023 | 93138 | Class II | Ongoing | Coapt ControlSeal Electrode, cutaneous EMG Electrode | 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. | accessdata.fda.gov |
| October 2, 2023 | 93137 | Class II | Ongoing | Coapt Dome Electrode, Gen2 system, cutaneous electrode | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Device, Prosthesis Alignment
- All makers of Hand, External Limb Component, Powered
Updated October 31, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.