Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd” (first 2017, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 94 days. Since 2017 the median was 94 days, against 106 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 4 | 88 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 182 |
| 2024 | 1 | 87 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| FHO | Pneumoperitoneum Needle | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
Review panels
Most recent Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241022 | Sterile single use tip cleaner (WK800-S10 , WK800-S20) | GEI | 2024-07-11 | 87 |
| K222828 | Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A | GCJ | 2023-03-20 | 182 |
| K172578 | Equipment Pouch | GCJ | 2017-12-07 | 101 |
| K172794 | Suction Irrigation Set | GCJ | 2017-11-29 | 75 |
| K172038 | Trocar | GCJ | 2017-10-27 | 114 |
| K172120 | Veress Needle | FHO | 2017-09-14 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Wickimed Supply Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd?
FDA lists 6 510(k) clearances under the applicant name “Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd” (first 2017, latest 2024), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd is 94 days. Since 2017: 94 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 4); FHO (Pneumoperitoneum Needle, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 6 Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.