Clearance Summary
I-PLANT MODEL 3500 (125IODINE BRACHYTHERAPY SEEDS)-STERILE received FDA 510(k) clearance under submission number K023242, sponsored by Implant Sciences Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-12-04.
- Submission: K023242
- Applicant / Sponsor: Implant Sciences Corp.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5730
- Decision date: 2002-12-04
Classification & Regulation
This clearance is catalogued under FDA product code KXK and 21 CFR 892.5730, within the Radiology review panel as a Class II device.