Single Use Circular Stapler CSC32
by Golden Stapler Surgical Co., Ltd
Single Use Circular Stapler CSC32 is a Class II device made by Golden Stapler Surgical Co., Ltd, cleared under FDA 510(k) K162707 on 14 Jul 2017 and listed in FDA GUDID since 14 Jun 2019 (UDI-DI 06946912217058), 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 | Number06946912217058 | Date14 Jun 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162707 | Date14 Jul 2017 | StatusActive |
Official records
- AccessGUDID record 06946912217058
- FDA 510(k) database K162707
Across registries
- FDA 510(k) K162707 decided 14 Jul 2017 Active
- FDA GUDID UDI-DI 06946912217058 listed 14 Jun 2019 Listed
Timeline
- Cleared FDA 510(k) K162707
- Listed FDA GUDID 06946912217058
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Single Use Circular Stapler
- Generic name
- Intraluminal circular stapler, single-use
- Model / reference
- CSC32
- Primary DI / UDI-DI
- 06946912217058
- 510(k) Number
- FDA product code
- GDW
- GMDN term
- Intraluminal circular stapler, single-use
- Device class
- Class II
- Regulation number
- 878.4750
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Intraluminal circular stapler, single-use.