Sti Medical Systems, LLC
United StatesFDA applicant, unverified
- Devices
- 4
What Sti Medical Systems, LLC makes
Sti Medical Systems, LLC manufactures medical devices for endoscopic procedures, including a colonoscopy assistant and a high-definition ultrasound system (UltrasightHD C31) with integrated telemedicine capabilities, such as remote imaging and viewer functions.
The company’s portfolio consists of Class II devices, all of which are listed via the FDA’s 510(k) pathway. These products are based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cervical Md, Model C10 Ref K072691
Regimes: 510(k) Registry: 510(k)Colonoscopy Assistant Ref K102949
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sti Medical Systems, LLC have in the registry?
The registry currently lists 4 devices for Sti Medical Systems, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sti Medical Systems, LLC's devices?
Among its 4 most recently registered devices, Sti Medical Systems, LLC has devices listed in FDA 510(k) (4 devices).
What risk classes do Sti Medical Systems, LLC's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sti Medical Systems, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sti Medical Systems, LLC in the registry?
The most recently registered devices listed for Sti Medical Systems, LLC include ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY, CERVICAL MD, MODEL C10, COLONOSCOPY ASSISTANT and ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE.