SSG10 #11
by Saeshin Precision Co., Ltd.
SSG10 #11 is a Class II device made by Saeshin Precision Co., Ltd., cleared under FDA 510(k) K233153 on 20 Sep 2024 and listed in FDA GUDID since 21 May 2025 (UDI-DI 08809260475038), 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 | Number08809260475038 | Date21 May 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233153 | Date20 Sep 2024 | StatusActive |
Official records
- AccessGUDID record 08809260475038
- FDA 510(k) database K233153
Across registries
- FDA 510(k) K233153 decided 20 Sep 2024 Active
- FDA GUDID UDI-DI 08809260475038 listed 21 May 2025 Listed
Timeline
- Cleared FDA 510(k) K233153
- Listed FDA GUDID 08809260475038
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SSG10
- Generic name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable
- Model / reference
- SSG10 #11
- Primary DI / UDI-DI
- 08809260475038
- 510(k) Number
- FDA product code
- HBC
- GMDN term
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable
- Device class
- Class II
- Regulation number
- 882.4360
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Bone/joint surgical power tool motorized handpiece/set, electric, reusable.