SofTIP Long
SofTIP Long (6002) is a Class II device made by Sentreheart, Inc, cleared under FDA 510(k) K090385 on 6 May 2009 and listed in FDA GUDID since 17 Sep 2018 (UDI-DI M95560020), 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 | NumberM95560020 | Date17 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK090385 | Date6 May 2009 | StatusActive |
Official records
- FDA 510(k) database K090385
Across registries
- FDA 510(k) K090385 decided 6 May 2009 Active
- FDA GUDID UDI-DI M95560020 listed 17 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K090385
- Listed FDA GUDID M95560020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SofTIP
- Generic name
- Open-surgery ligator guide sheath
- Model / Ref / Catalog
- Long, 6002
- Primary DI / UDI-DI
- M95560020
- 510(k) Number
- FDA product code
- GAT
- GMDN term
- Open-surgery ligator guide sheath
- Device class
- Class II
- Regulation number
- 878.5000
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 22.5 Centimeter
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