Handlike HD-CSH01
by Hunan Handlike Minimally Invasive Surgery Co., Ltd.
Handlike HD-CSH01 is a device classified as Unclassified made by Hunan Handlike Minimally Invasive Surgery Co., Ltd., cleared under FDA 510(k) K233036 on 18 Jun 2024 and listed in FDA GUDID since 16 Jul 2024 (UDI-DI 06957270304175), 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 | Number06957270304175 | Date16 Jul 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK233036 | Date18 Jun 2024 | StatusActive |
Official records
- AccessGUDID record 06957270304175
- FDA 510(k) database K233036
Across registries
- FDA 510(k) K233036 decided 18 Jun 2024 Active
- FDA GUDID UDI-DI 06957270304175 listed 16 Jul 2024 Listed
Timeline
- Cleared FDA 510(k) K233036
- Listed FDA GUDID 06957270304175
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Handlike
- Generic name
- Soft-tissue ultrasonic surgical system handpiece, reusable
- Model / reference
- HD-CSH01
- Primary DI / UDI-DI
- 06957270304175
- 510(k) Number
- FDA product code
- LFL
- GMDN term
- Soft-tissue ultrasonic surgical system handpiece, reusable
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Hydrogen Peroxide
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