Clearance Summary
THE OB-GYN CONCEPTS VAGINAL ASPIRATOR received FDA 510(k) clearance under submission number K863610, sponsored by Ob/Gyn Concepts, Ltd.. 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 1987-01-07.
- Submission: K863610
- Applicant / Sponsor: Ob/Gyn Concepts, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1987-01-07
Classification & Regulation
This clearance is catalogued under FDA product code KOH and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.