Clearance Summary
ASSISTO Universal Applicator Clamping Device received FDA 510(k) clearance under submission number K201279, sponsored by Geomed Medizin-Technik GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-07-10.
- Submission: K201279
- Applicant / Sponsor: Geomed Medizin-Technik GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2020-07-10
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.