Macan MC-IS
Macan MC-IS is a Class II device made by Macan Manufacturing, cleared under FDA 510(k) K170054 on 2 Oct 2017 and listed in FDA GUDID since 25 Oct 2018 (UDI-DI 00853404007522), active as of 22 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 | Number00853404007522 | Date25 Oct 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170054 | Date2 Oct 2017 | StatusActive |
Official records
- AccessGUDID record 00853404007522
- FDA 510(k) database K170054
Across registries
- FDA 510(k) K170054 decided 2 Oct 2017 Active
- FDA GUDID UDI-DI 00853404007522 listed 25 Oct 2018 Listed
Timeline
- Cleared FDA 510(k) K170054
- Listed FDA GUDID 00853404007522
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Macan
- Generic name
- Electrosurgical system
- Model / reference
- MC-IS
- Primary DI / UDI-DI
- 00853404007522
- 510(k) Number
- FDA product code
- GEI
- GMDN term
- Electrosurgical system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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