Astel, Inc.
South KoreaFDA applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Astel, Inc. makes
Astel, Inc. manufactures radiofrequency ablation (RFA) devices, including the RFA-1717DIG and RFA-1717DIC models, designed for tissue ablation procedures. These devices are intended for controlled thermal destruction of targeted tissue, commonly used in oncology and other medical specialties.
The company’s portfolio is regulated under FDA Class II devices, with relevant products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, adhering to US regulatory requirements. The manufacturer operates from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
Rfa-1717DIG, Rfa-1717DIC Ref K212051
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 689531031
FDA establishments
- Astel.inc Yuseong-gu Daejeon · KR FEI 3022131441
Frequently asked questions
How many devices does Astel, Inc. have in the registry?
The registry currently lists 3 devices for Astel, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Astel, Inc.'s devices?
Among its 3 most recently registered devices, Astel, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Astel, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Astel, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Astel, Inc. in the registry?
The most recently registered devices listed for Astel, Inc. include RFA-1717DIG, RFA-1717DIC and RFA-1717DIG, RFA-1717DIC.
Which FDA establishments are linked to Astel, Inc.?
1 FDA establishment is linked to Astel, Inc. in the registry; they are listed on the company page.