510(k) K240523
K240523 is an FDA 510(k) premarket notification submitted by Shenzhen Vitavitro Biotech Co., Ltd. for the device "VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)". The FDA issued a decision of Substantially Equivalent on November 15, 2024. The device falls under product code MQE (Needle, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6100. Shenzhen Vitavitro Biotech Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 2024
- Date Received
- February 23, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6100
- Review Panel
- OB
- Submission Type