Changzhou Waston Medical Appliance Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Changzhou Waston Medical Appliance Co., Ltd.” (first 2010, latest 2023), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 241 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 3 | 241 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 638 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Changzhou Waston Medical Appliance Co., Ltd. took a median 638 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GDW | Staple, Implantable | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
Review panels
Most recent Changzhou Waston Medical Appliance Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211197 | Disposable Endoscopic Cutter Stapler and Cartridge | GDW | 2023-01-19 | 638 |
| K151062 | WASTON Metallic Intramedullary Nail System | HSB | 2015-12-17 | 241 |
| K150684 | WASTON General Spinal System | MNI | 2015-11-18 | 246 |
| K151057 | WASTON Metallic Bone Plate and Screw Systems | HRS | 2015-08-10 | 112 |
| K100386 | DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 | GDW | 2010-03-01 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Changzhou Waston Medical Appliance 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.
- Changzhou Sifary Medical Technology Co., Ltd. (5 510(k)s)
- Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. (4 510(k)s)
- Changzhou Kangdi Medical Stapler Co., Ltd. (4 510(k)s)
- Changzhou Bomedent Medical Technology Co.,Ltd (3 510(k)s)
- Changzhou Combat Protective Equipment Co., Ltd. (3 510(k)s)
- Changzhou Endoclean Medical Device Co., Ltd. (3 510(k)s)
- Changzhou Holymed Products Co., Ltd. (3 510(k)s)
- Changzhou Universal Medical Equipment Co., Ltd. (3 510(k)s)
- Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd (3 510(k)s)
- Changzhou Dean Medical Instrument Co, Ltd. (2 510(k)s)
- Changzhou Dingjian Medical Appliance Co., Ltd. (2 510(k)s)
- Changzhou Orthmed Medical Instrument Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Changzhou Waston Medical Appliance Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Changzhou Waston Medical Appliance Co., Ltd.” (first 2010, latest 2023), across 4 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 Changzhou Waston Medical Appliance Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Changzhou Waston Medical Appliance Co., Ltd. is 241 days.
Which FDA product codes appear under Changzhou Waston Medical Appliance Co., Ltd.?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 2); HRS (Plate, Fixation, Bone, 1); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Next steps
- See all 5 Changzhou Waston Medical Appliance Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GDW, Changzhou Waston Medical Appliance 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.