K240523
- 510(k) number
- K240523
- Device name
- VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
- Applicant
- Shenzhen Vitavitro Biotech Co., Ltd. CN
- Product code
- MQE — Needle, Assisted Reproduction
- Decision date
- 2024-11-15
- Date received
- 2024-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K240523.pdf
Official FDA record: K240523
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.