Clearance Summary
O'NEIL OBSTETRIC CUP received FDA 510(k) clearance under submission number K840008, sponsored by Go Medical Industries Pty. , 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 1984-04-25.
- Submission: K840008
- Applicant / Sponsor: Go Medical Industries Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4340
- Decision date: 1984-04-25
Classification & Regulation
This clearance is catalogued under FDA product code HDB and 21 CFR 884.4340, within the Obstetrics/Gynecology review panel as a Class II device.