Clearance Summary
GLOVE-N-GEL AMNIOTOMY KIT received FDA 510(k) clearance under submission number K910518, sponsored by Epcom Medical Systems, 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 1991-05-09.
- Submission: K910518
- Applicant / Sponsor: Epcom Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1991-05-09
Classification & Regulation
This clearance is catalogued under FDA product code HGE and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.