FDA 510(k) Premarket Notification — K212561
510(k) Premarket Notification Database · U.S. Food & Drug Administration
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510(k) Premarket Notification
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FDA 510(k) PREMARKET NOTIFICATION
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number
K212561
Device Name
MTX-C1
Applicant
ILOODA Co., Ltd
120, Jangan-Ro 458 Beon-Gil, Jangan-Gu
Suwon-Si, KR 16200
120, Jangan-Ro 458 Beon-Gil, Jangan-Gu
Suwon-Si, KR 16200
Applicant Contact
Yu-Jung Na
Correspondent
Mtech Group
7505 Fannin St. Ste 610
Houston, TX 77054
7505 Fannin St. Ste 610
Houston, TX 77054
Correspondent Contact
Dave Kim
Regulatory Details
| Regulation Number | 878.4400 |
|---|---|
| Classification Product Code | GEI |
| Regulation Medical Specialty | General & Plastic Surgery |
| 510k Review Panel | General & Plastic Surgery |
Decision
| Date Received | 08/13/2021 |
|---|---|
| Decision Date | 09/27/2022 |
| Decision | Substantially Equivalent (SESE) |
| Summary | Summary |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
Page Last Updated: 12/20/2024 — Source: FDA.gov 510(k) Premarket Notification Database
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Page Footer & Navigation
This page contains FDA website navigation links and footer information from the official 510(k) Premarket Notification database printout. The notification record confirms that MTX-C1 (K212561) received a Substantially Equivalent (SESE) determination on September 27, 2022, clearing the device for marketing in the United States.
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Additional References
This page contains additional FDA database cross-reference links, including product classification, CFR search, and the downloadable 510(k) summary PDF (K212561.pdf) hosted on the FDA AccessData portal.