SofTIP 60-02
SofTIP 60-02 (FG-0008) is a Class II device made by Atricure, Inc., cleared under FDA 510(k) K090385 on 6 May 2009 and listed in FDA GUDID since 11 Jan 2021 (UDI-DI 10840143901812), 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 | Number10840143901812 | Date11 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090385 | Date6 May 2009 | StatusActive |
Official records
- AccessGUDID record 10840143901812
- FDA 510(k) database K090385
Across registries
- FDA 510(k) K090385 decided 6 May 2009 Active
- FDA GUDID UDI-DI 10840143901812 listed 11 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K090385
- Listed FDA GUDID 10840143901812
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SofTIP
- Generic name
- Suture cutter, single-use
- Model / Ref / Catalog
- 60-02, FG-0008
- Primary DI / UDI-DI
- 10840143901812
- 510(k) Number
- FDA product code
- GAT
- GMDN term
- Suture cutter, single-use
- Device class
- Class II
- Regulation number
- 878.5000
- GUDID distribution status
- In Commercial Distribution
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