VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
FDA 510(k) K240523 · Shenzhen Vitavitro Biotech Co., Ltd.
510(k) numberK240523
Submission
- 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.
Shenzhen, CN - Received
- February 23, 2024
- Decision date
- November 15, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQE – Needle, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6100
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval…MQE · Traditional | Gimbo Medical Technology Shenzhen Co., Ltd. | 06/15/2026SE |
| K232163 | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration NeedleMQE · Traditional | Zhejiang Horizon Medical Technology Co., Ltd. | 02/22/2024SE |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen…MQE · Traditional | Allwin Medical Devices, Inc. | 11/25/2019SE |
| K191291 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Special | CooperSurgical, Inc. | 06/12/2019SE |
| K182959 | Wallace Dual Lumen Oocyte Recovery SystemMQE · Traditional | CooperSurgical, Inc. | 05/10/2019SE |
| K171625 | Single Lumen Ovum Aspiration NeedlesMQE · Special | Willian A. Cook Australia Pty, Ltd. | 01/12/2018SE |
| K171611 | Double Lumen Ovum Aspiration NeedlesMQE · Special | William A. Cook Australia Pty. , Ltd. | 12/15/2017SE |
| K172050 | Follicle Aspiration Set, Reduced Single LumenMQE · Traditional | Vitrolife Sweden AB | 11/21/2017SE |
| K162881 | Kitazato OPU NeedlesMQE · Traditional | Kitazato Corporation | 07/11/2017SE |
| K161970 | Follicle Aspiration SetMQE · Traditional | Vitrolife Sweden AB | 06/14/2017SE |
More from Vitrolife Sweden AB
| 510(k) | Device | Decision |
|---|---|---|
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)MQF · Traditional | 08/16/2024SE |
| K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient MediumMQL · Traditional | 02/01/2022SE |
| K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing…MQL · Traditional | 10/16/2020SE |
| K191063 | 1-Step Culture MediumMQL · Traditional | 08/23/2019SE |
Questions and answers
When was VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) cleared by the FDA?
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (K240523) received a 510(k) decision of Substantially Equivalent on November 15, 2024, 266 days after the submission was received.
What is the product code of K240523?
The FDA product code is MQE – Needle, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6100.