CQ'ENCE Circular Stapler 28mm CS28
CQ'ENCE Circular Stapler 28mm CS28 is a Class II device made by Secqure Surgical, Corp., cleared under FDA 510(k) K120179 on 23 May 2012 and listed in FDA GUDID since 25 Oct 2017 (UDI-DI B092CS280), 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 | NumberB092CS280 | Date25 Oct 2017 | StatusListed |
| United States | FDA 510(k) | NumberK120179 | Date23 May 2012 | StatusActive |
Official records
- FDA 510(k) database K120179
Across registries
- FDA 510(k) K120179 decided 23 May 2012 Active
- FDA GUDID UDI-DI B092CS280 listed 25 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K120179
- Listed FDA GUDID B092CS280
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CQ'ENCE Circular Stapler 28mm
- Generic name
- Surgical staple loading unit, non-cutting
- Model / Ref / Catalog
- CS28
- Primary DI / UDI-DI
- B092CS280
- 510(k) Number
- FDA product code
- GDW
- GMDN term
- Surgical staple loading unit, non-cutting
- Device class
- Class II
- Regulation number
- 878.4750
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Surgical staple loading unit, non-cutting.