Clearance Summary
M/29TM - PRESSURE INJECTABLE received FDA 510(k) clearance under submission number K111939, sponsored by Flexicath , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2012-07-11.
- Submission: K111939
- Applicant / Sponsor: Flexicath , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 2012-07-11
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.