Zhejiang Chuangxiang Medical Technology Co., Ltd.: FDA clearances and approvals
Zhejiang Chuangxiang Medical Technology Co., Ltd. has 14 FDA 510(k) clearances (first 2018, latest 2026), across 10 product codes in 1 review panel. Median 510(k) review time: 186 days. Since 2017 its median was 186 days, against 148 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 3 | 175 |
| 2019 | 1 | 132 |
| 2020 | 1 | 255 |
| 2021 | 0 | — |
| 2022 | 4 | 192 |
| 2023 | 2 | 177 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 3 | 214 |
Review time against the same product codes
Since 2017, Zhejiang Chuangxiang Medical Technology Co., Ltd.'s cleared 510(k)s took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | 3 | 3 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | 2 | 2 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 2 | 2 |
| FAD | Stent, Ureteral | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
Review panels
Most recent Zhejiang Chuangxiang Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260410 | Single Use Ureteral Access Sheath | FED | 2026-09-11 | 214 |
| K253132 | Single use stone retrieval balloons | FGE | 2026-03-06 | 162 |
| K251890 | Disposable Ureteral Stents | FAD | 2026-02-20 | 245 |
| K230773 | Endoscopy Irrigation Tubing | OCX | 2023-11-21 | 245 |
| K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | OCX | 2023-09-08 | 109 |
| K220063 | Single Use Cytology Brush | FDX | 2022-07-28 | 199 |
| K212669 | Single Use Hemoclip | PKL | 2022-05-27 | 277 |
| K220065 | Single Use Ureteral Access Sheath | FED | 2022-05-25 | 135 |
| K212668 | Sclerotherapy Needle | FBK | 2022-02-23 | 184 |
| K191900 | Single Use Grasping Forceps | OCZ | 2020-03-27 | 255 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Zhejiang Chuangxiang Medical Technology 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 Zhejiang Chuangxiang Medical Technology Co., Ltd. have?
Zhejiang Chuangxiang Medical Technology Co., Ltd. has 14 FDA 510(k) clearances (first 2018, latest 2026), across 10 product codes in 1 review panel.
How long does FDA take to clear Zhejiang Chuangxiang Medical Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Zhejiang Chuangxiang Medical Technology Co., Ltd.'s cleared 510(k)s is 186 days. Since 2017: 186 days, versus 148 days for all cleared 510(k)s in the same product codes.
What devices does Zhejiang Chuangxiang Medical Technology Co., Ltd. make?
Its most frequent FDA product codes are OCX (Endoscopic Irrigation/Suction System, 3); FED (Endoscopic Access Overtube, Gastroenterology-Urology, 2); PKL (Hemostatic Metal Clip For The Gi Tract, 2).
Has Zhejiang Chuangxiang Medical Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Zhejiang Chuangxiang Medical Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 14 Zhejiang Chuangxiang Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OCX, Zhejiang Chuangxiang Medical Technology 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.