Clearance Summary
IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM received FDA 510(k) clearance under submission number K010166, sponsored by Imagyn Medical Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-12-03.
- Submission: K010166
- Applicant / Sponsor: Imagyn Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5650
- Decision date: 2001-12-03
Classification & Regulation
This clearance is catalogued under FDA product code IWJ and 21 CFR 892.5650, within the Radiology review panel as a Class I device.