Data / Medical devices / South Korea / Chungwoo Co., Ltd.
Chungwoo Co., Ltd.: FDA-registered device maker in Geumcheon-gu Seoul, South Korea, 2 510(k) clearances
Chungwoo Co., Ltd. is registered with the FDA (registration 3010952064) in Geumcheon-gu Seoul, South Korea. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010952064
- Address
- (Gasan-dong, Woolim Lionsvalley-2), 615~617, 2, Gasandigital1-ro, Geumcheon-gu Seoul, South Korea, 08591
- Owner or operator
- CHUNGWOO CO., LTD. (10087784)
- Roles
- Manufacturer
- First device listed
- April 10, 2023
- Registered through
- 2026
- Brand names listed
- APOLEX Tite (Model: CWM-910T), Bi-polar Hand piece (Model: CWM-930S-Y01), Bi-polar Hand piece Cable (Model: CWM-930S-H20), Bi-polar Hand piece Suction Filter (Model: CWM-930S-Y02), ELLISYS SENSE (Model: CWM-930S), Electrode LIFT (Model: 2X80), Electrode LIPO (Model: 4X300), Electrode SMART (Model: 2X180) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 23, 2024 | K233120 | CWM-930S, FIXER DV9 | GEI | Substantially Equivalent | Chungwoo Co., Ltd. | accessdata.fda.gov |
| March 21, 2023 | K222709 | Retraction, CWM-910T, APOLEX Tite | GEI | Substantially Equivalent | Chungwoo Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.