Clearance Summary
REMOTE CONTROL RADIOISOTOPE APPLICATOR received FDA 510(k) clearance under submission number K943109, sponsored by Inter-Pal GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-02-09.
- Submission: K943109
- Applicant / Sponsor: Inter-Pal GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 1995-02-09
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.