Clearance Summary
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) received FDA 510(k) clearance under submission number K240523, sponsored by Shenzhen Vitavitro Biotech Co., 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 2024-11-15.
- Submission: K240523
- Applicant / Sponsor: Shenzhen Vitavitro Biotech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6100
- Decision date: 2024-11-15
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.