Data / Medical devices / South Korea / Tentech Inc.
Tentech Inc.: FDA-registered device maker in Seoul, South Korea, 2 510(k) clearances
Tentech Inc. is registered with the FDA (registration 3025606176) in Seoul, South Korea. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 20, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025606176
- Address
- #802 Ace Techno Tower 5th, 20, Digital-ro 31-gil, Guro-gu, Seoul, South Korea, 08380
- Owner or operator
- TENTECH Inc. (10086925)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- December 22, 2022
- Registered through
- 2026
- Brand names listed
- 10PL, 10THERMA, XTHERMA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| December 20, 2023 | K232992 | 10THERMA | GEI | Substantially Equivalent | Tentech, Inc. | accessdata.fda.gov |
| November 10, 2022 | K220794 | 10PL | ONF | Substantially Equivalent | Tentech Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Updated December 20, 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.