Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Cixi Zhejiang, CN
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. appears in FDA device records in Cixi Zhejiang, CN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. between 2019 and 2024. The busiest year on record is 2019, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2019 | 2 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240376 | Electroporation System (N3000) | OAB | Substantially Equivalent | |
| K221995 | Gas Insufflator | HIF | Substantially Equivalent | |
| K212614 | Ultrasonic Scalpel System | LFL | Substantially Equivalent | |
| K210488 | Ultrasonic Surgical & Electrosurgical Generator | GEI | Substantially Equivalent | |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | HET | Substantially Equivalent | |
| K183153 | Microwave Ablation System | NEY | Substantially Equivalent | |
| K190052 | Radio Frequency Ablation System | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015540957 | 3015540957 | SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. | No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, Cixi Zhejiang 315301 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- LFLInstrument, Ultrasonic Surgical
- HIFInsufflator, Laparoscopic
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- OABLow Energy Direct Current Thermal Ablation System
- NEYSystem, Ablation, Microwave And Accessories
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain