Data / Medical devices / South Korea / RF Medical Co., Ltd
RF Medical Co., Ltd: FDA-registered device maker in Seoul, South Korea, 4 510(k) clearances
RF Medical Co., Ltd is registered with the FDA (registration 3015136673) in Seoul, South Korea. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 4, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015136673
- Address
- #502~#507,#511,#601, 254 Beotkkot-ro, Geumcheon-gu, Seoul, South Korea, 08513
- Owner or operator
- RF MEDICAL CO., LTD (10059293)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 18, 2018
- Registered through
- 2026
- Brand names listed
- BIG-TIP (BT 0605B), BIG-TIP (BT 0605PB), BIG-TIP (BT 0607PB), BIG-TIP (BT 0610B), BIG-TIP (BT 0610PB), BIG-TIP (BT 0615B), BIG-TIP (BT 0615PB), BIG-TIP (BT 0620B) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle Guide Kit | OIJ | 2 | Manufacturer | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrosurgical | JOS | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | 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 |
|---|---|---|---|---|---|---|
| October 4, 2023 | K232763 | Electrode Handpieces (VCT, RFTV, BMDT series) | GEI | Substantially Equivalent | RF Medical Co., Ltd. | accessdata.fda.gov |
| September 2, 2022 | K221277 | Mygen M-3004 RF Generator M-3004 | GEI | Substantially Equivalent | RF Medical Co., Ltd. | accessdata.fda.gov |
| August 3, 2020 | K193355 | Electrodes Handpieces for Mygen V-1000 RF System | GEI | Substantially Equivalent | RF Medical Co., Ltd. | accessdata.fda.gov |
| December 11, 2018 | K180999 | Mygen V-1000 RF System | GEI | Substantially Equivalent | RF Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Electrosurgical
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Biopsy Needle Guide Kit
- All makers of Dilator, Cervical, Fixed Size
Updated October 4, 2023. 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.