Clearance Summary
WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 received FDA 510(k) clearance under submission number K000628, sponsored by Sims Portex , 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 2000-03-13.
- Submission: K000628
- Applicant / Sponsor: Sims Portex , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6100
- Decision date: 2000-03-13
Classification & Regulation
This clearance is catalogued under FDA product code MQE and 21 CFR 884.6100, within the Obstetrics/Gynecology review panel as a Class II device.