Clearance Summary
ENDOCYTE received FDA 510(k) clearance under submission number K843941, sponsored by Gyneco, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1985-02-25.
- Submission: K843941
- Applicant / Sponsor: Gyneco, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1100
- Decision date: 1985-02-25
Classification & Regulation
This clearance is catalogued under FDA product code HFE and 21 CFR 884.1100, within the Obstetrics/Gynecology review panel as a Class II device.