Data / Medical devices / China / Surgnova Healthcare Technologies (zhejiang) Co., Ltd.
Surgnova Healthcare Technologies (zhejiang) Co., Ltd.: FDA-registered device maker in Cixi Zhejiang, China, 7 510(k) clearances
Surgnova Healthcare Technologies (zhejiang) Co., Ltd. is registered with the FDA (registration 3015540957) in Cixi Zhejiang, China. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015540957
- Address
- No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, Cixi Zhejiang, China, 315301
- Owner or operator
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (10060870)
- Roles
- Manufacturer
- First device listed
- July 5, 2019
- Registered through
- 2026
- Brand names listed
- Electroporation System (N3000), Electrosurgical mode of Ultrosonic Surgical & Eletrosurgical Generator, Model: SC300ES, SC200ES, SC100ES, Energy Generator, Model: ES300, ES200, ES100, Gas Insufflator, Microwave Ablation System, model: M150E, Radio Frequency Ablation System, model: R150E, Ultrasonic Scalpel System, Model: SC100E, Ultrasonic Surgical mode of Ultrasonic Surgical & Electrosurgical Generator, Model: SC300ES, SC200ES, SC100ES, SC200 and more
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 |
| Insufflator, Laparoscopic | HIF | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, Gynecologic (And Accessories) | HET | 2 | Manufacturer | accessdata.fda.gov |
| Low Energy Direct Current Thermal Ablation System | OAB | 2 | Manufacturer | accessdata.fda.gov |
| System, Ablation, Microwave And Accessories | NEY | 2 | Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | 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 |
|---|---|---|---|---|---|---|
| October 4, 2024 | K240376 | Electroporation System (N3000) | OAB | Substantially Equivalent | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | accessdata.fda.gov |
| March 28, 2023 | K221995 | Gas Insufflator | HIF | Substantially Equivalent | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | accessdata.fda.gov |
| July 18, 2022 | K212614 | Ultrasonic Scalpel System | LFL | Substantially Equivalent | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | accessdata.fda.gov |
| October 25, 2021 | K210488 | Ultrasonic Surgical & Electrosurgical Generator | GEI | Substantially Equivalent | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | accessdata.fda.gov |
| October 13, 2021 | K210116 | Video Endoscopy System, 3D Video Endoscopy System | HET | Substantially Equivalent | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | accessdata.fda.gov |
| July 8, 2019 | K183153 | Microwave Ablation System | NEY | Substantially Equivalent | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | accessdata.fda.gov |
| June 25, 2019 | K190052 | Radio Frequency Ablation System | GEI | Substantially Equivalent | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Instrument, Ultrasonic Surgical
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Laparoscope, Gynecologic (And Accessories)
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of System, Ablation, Microwave And Accessories
Updated October 4, 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.