Clearance Summary
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S received FDA 510(k) clearance under submission number K012068, 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 2001-08-03.
- Submission: K012068
- Applicant / Sponsor: Sims Portex , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6100
- Decision date: 2001-08-03
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.