Bistool
South KoreaFDA applicant, unverified FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Bistool makes
Bistool manufactures SOFTXIL, a medical device designed for [specific clinical use implied by Class II—likely a reusable or single-use surgical instrument, implant, or orthopedic fixation tool, though exact function not detailed]. The product falls under Class II regulatory classification, indicating moderate risk and requiring pre-market notification (510(k)) clearance in the US.
SOFTXIL is regulated under the US Food and Drug Administration’s 510(k) pathway as a Class II device and is listed in the FDA’s 510(k) database. The manufacturer operates from the United States.
Catalogue
Softxil Ref K171851
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Bistool Inc Seoul · KR FEI 3014664527
Frequently asked questions
How many devices does Bistool have in the registry?
The registry currently lists 1 device for Bistool. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bistool's devices?
Among its 1 most recently registered device, Bistool has devices listed in FDA 510(k) (1 device).
What risk classes do Bistool's devices fall under?
Among its 1 most recently registered device, the classes recorded for Bistool's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bistool in the registry?
The most recently registered devices listed for Bistool include SOFTXIL.
Which FDA establishments are linked to Bistool?
1 FDA establishment is linked to Bistool in the registry; they are listed on the company page.