AccuShape® ACS-002
by Medcad
AccuShape® ACS-002 is a Class II device made by Medcad, cleared under FDA 510(k) K110684 on 24 Jun 2011 and listed in FDA GUDID since 28 Feb 2019 (UDI-DI 00810007630014), 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 | Number00810007630014 | Date28 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110684 | Date24 Jun 2011 | StatusActive |
Official records
- AccessGUDID record 00810007630014
- FDA 510(k) database K110684
Across registries
- FDA 510(k) K110684 decided 24 Jun 2011 Active
- FDA GUDID UDI-DI 00810007630014 listed 28 Feb 2019 Listed
Timeline
- Cleared FDA 510(k) K110684
- Listed FDA GUDID 00810007630014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AccuShape®
- Generic name
- Cranioplasty plate, non-alterable
- Model / Ref / Catalog
- ACS-002
- Primary DI / UDI-DI
- 00810007630014
- 510(k) Number
- FDA product code
- GXN
- GMDN term
- Cranioplasty plate, non-alterable
- Device class
- Class II
- Regulation number
- 882.5330
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization