Data / Medical devices / China / Hunan Handlike Minimally Invasive Surgery Co., Ltd.
Hunan Handlike Minimally Invasive Surgery Co., Ltd.: FDA-registered device maker in Changsha Hunan, China, 2 510(k) clearances
Hunan Handlike Minimally Invasive Surgery Co., Ltd. is registered with the FDA (registration 3010594949) in Changsha Hunan, China. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010594949
- Address
- A4,Lugu Yuyuan,#27,Wenxuan Rd,High-tech Zone, Changsha Hunan, China, 410205
- Owner or operator
- Hunan Handlike Minimally Invasive Surgery Co.,Ltd. (10045334)
- Roles
- Manufacturer
- First device listed
- November 6, 2013
- Registered through
- 2026
- Brand names listed
- Cholangiography Forceps, Reference code HD1010116, HD1020116, HD1010106, HD1010136, Curved Needle Holder (Single Action), Reference code HD1020431, HD1020401, Disposable endoscopic surgical instruments, Laparoscopic accessories, Reusable endoscopic surgical instruments, Straight Needle Holder (Single Action), Reference code HD1020432, HD1020402, Ultrasonic Surgical System, model HD-CSXT-001
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Ultrasonic Surgical | LFL | U | Manufacturer | accessdata.fda.gov |
| Laparoscopic Accessories, Gynecologic | NWV | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 2024 | K233036 | Ultrasonic Surgical System | LFL | Substantially Equivalent | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | accessdata.fda.gov |
| February 13, 2018 | K171825 | Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument | GEI | Substantially Equivalent | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laparoscopic Accessories, Gynecologic
- All makers of Instrument, Ultrasonic Surgical
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated June 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.