Clearance Summary
ENDO I/A Y SET received FDA 510(k) clearance under submission number K913979, sponsored by Snowden-Pencer. 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 1991-11-27.
- Submission: K913979
- Applicant / Sponsor: Snowden-Pencer
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1991-11-27
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.