Access Needle FG3018
by Shanghai Kinetic Medical Co., Ltd.
Access Needle FG3018 is a Class II device made by Shanghai Kinetic Medical Co., Ltd., cleared under FDA 510(k) K113742 on 17 Sep 2012 and listed in FDA GUDID since 31 May 2020 (UDI-DI 06938695537751), 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 | Number06938695537751 | Date31 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113742 | Date17 Sep 2012 | StatusActive |
Official records
- AccessGUDID record 06938695537751
- FDA 510(k) database K113742
Across registries
- FDA 510(k) K113742 decided 17 Sep 2012 Active
- FDA GUDID UDI-DI 06938695537751 listed 31 May 2020 Listed
Timeline
- Cleared FDA 510(k) K113742
- Listed FDA GUDID 06938695537751
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Access Needle
- Generic name
- Bone access channel kit
- Model / Ref / Catalog
- FG3018
- Primary DI / UDI-DI
- 06938695537751
- 510(k) Number
- FDA product code
- NDN, HRX
- GMDN term
- Bone access channel kit
- Device class
- Class II
- Regulation number
- 888.3027, 888.1100
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 3 MillimeterLength — 115 Millimeter
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