SECQURE Ultimate CQ3443ULT
SECQURE Ultimate CQ3443ULT is a Class I device made by Secqure Surgical, Corp., cleared under FDA 510(k) K081398 on 6 Feb 2009 and listed in FDA GUDID since 19 Sep 2017 (UDI-DI 00863634000477), 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 | Number00863634000477 | Date19 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081398 | Date6 Feb 2009 | StatusActive |
Official records
- AccessGUDID record 00863634000477
- FDA 510(k) database K081398
Across registries
- FDA 510(k) K081398 decided 6 Feb 2009 Active
- FDA GUDID UDI-DI 00863634000477 listed 19 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K081398
- Listed FDA GUDID 00863634000477
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SECQURE Ultimate
- Generic name
- Tissue extraction bag
- Model / reference
- CQ3443ULT
- Primary DI / UDI-DI
- 00863634000477
- 510(k) Number
- FDA product code
- KGY
- GMDN term
- Tissue extraction bag
- Device class
- Class I
- Regulation number
- 878.4100
- GUDID distribution status
- In Commercial Distribution
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