Complete Calibrate 1
by Coapt, LLC
Complete Calibrate 1 is a device of GMDN type myoelectric hand prosthesis (FDA Class II; FDA product code GXY, Electrode, Cutaneous) made by Coapt, LLC, cleared under FDA 510(k) K162891 on 14 Apr 2017 and listed in FDA GUDID since 8 May 2018 (UDI-DI B618D0), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB618D0 | Date8 May 2018 | StatusListed |
| United States | FDA 510(k) | NumberK162891 | Date14 Apr 2017 | StatusActive |
Official records
- FDA 510(k) database K162891
Across registries
- FDA 510(k) K162891 decided 14 Apr 2017 Active
- FDA GUDID UDI-DI B618D0 listed 8 May 2018 Listed
Timeline
- Cleared FDA 510(k) K162891
- Listed FDA GUDID B618D0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Complete Calibrate
- Generic name
- Myoelectric hand prosthesis
- Model / reference
- 1
- Primary DI / UDI-DI
- B618D0
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Myoelectric hand prosthesis
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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