Clearance Summary
ENDOCATER received FDA 510(k) clearance under submission number K863393, sponsored by The Hygenic Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 1987-06-11.
- Submission: K863393
- Applicant / Sponsor: The Hygenic Corp.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 1987-06-11
Classification & Regulation
This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.