Forma Cart FS10001
Forma Cart FS10001 is a Class I device made by Formatk Systems Ltd, cleared under FDA 510(k) K160195 on 15 Apr 2016 and listed in FDA GUDID since 18 Aug 2017 (UDI-DI 07290016681109), 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 | Number07290016681109 | Date18 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160195 | Date15 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 07290016681109
- FDA 510(k) database K160195
Across registries
- FDA 510(k) K160195 decided 15 Apr 2016 Active
- FDA GUDID UDI-DI 07290016681109 listed 18 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K160195
- Listed FDA GUDID 07290016681109
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Forma Cart
- Generic name
- Electromechanical device/system transport trolley
- Model / Ref / Catalog
- FS10001
- Primary DI / UDI-DI
- 07290016681109
- 510(k) Number
- FDA product code
- BZN
- GMDN term
- Electromechanical device/system transport trolley
- Device class
- Class I
- Regulation number
- 868.6175
- GUDID distribution status
- In Commercial Distribution
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