Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.: FDA clearances and approvals
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. has 7 FDA 510(k) clearances (first 2019, latest 2024), across 6 product codes in 2 review panels. Median 510(k) review time: 248 days. Since 2017 its median was 248 days, against 121 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 2 | 200 |
| 2020 | 0 | — |
| 2021 | 2 | 258 |
| 2022 | 1 | 334 |
| 2023 | 1 | 265 |
| 2024 | 1 | 240 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.'s cleared 510(k)s took a median 248 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| LFL | Instrument, Ultrasonic Surgical | 1 | 1 |
| NEY | System, Ablation, Microwave And Accessories | 1 | 1 |
| OAB | Low Energy Direct Current Thermal Ablation System | 1 | 1 |
Review panels
Most recent Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240376 | Electroporation System (N3000) | OAB | 2024-10-04 | 240 |
| K221995 | Gas Insufflator | HIF | 2023-03-28 | 265 |
| K212614 | Ultrasonic Scalpel System | LFL | 2022-07-18 | 334 |
| K210488 | Ultrasonic Surgical & Electrosurgical Generator | GEI | 2021-10-25 | 248 |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | HET | 2021-10-13 | 267 |
| K183153 | Microwave Ablation System | NEY | 2019-07-08 | 236 |
| K190052 | Radio Frequency Ablation System | GEI | 2019-06-25 | 165 |
Recalls
openFDA lists no recalls under a recalling firm named Surgnova Healthcare Technologies (Zhejiang) Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. have?
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. has 7 FDA 510(k) clearances (first 2019, latest 2024), across 6 product codes in 2 review panels.
How long does FDA take to clear Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.'s cleared 510(k)s is 248 days. Since 2017: 248 days, versus 121 days for all cleared 510(k)s in the same product codes.
What devices does Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); HET (Laparoscope, Gynecologic (And Accessories), 1); HIF (Insufflator, Laparoscopic, 1).
Has Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Related entities may recall under other names.
Next steps
- See all 7 Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.