Clearance Summary
GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, received FDA 510(k) clearance under submission number K991236, sponsored by CIVCO Medical Instruments Co., 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 1999-06-02.
- Submission: K991236
- Applicant / Sponsor: CIVCO Medical Instruments Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1999-06-02
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.