Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
FDA 510(k) K232163 · Zhejiang Horizon Medical Technology Co., Ltd.
510(k) numberK232163
Submission
- Device name
- Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
- Applicant
- Zhejiang Horizon Medical Technology Co., Ltd.
Jiaxing, CN - Received
- July 21, 2023
- Decision date
- February 22, 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 |
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double…MQE · Traditional | Shenzhen Vitavitro Biotech Co., Ltd. | 11/15/2024SE |
| 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 |
|---|---|---|
| K223265 | CryoX Vitrification Freeze Kit / Thaw KitMQL · Traditional | 05/11/2023SE |
Questions and answers
When was Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle cleared by the FDA?
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle (K232163) received a 510(k) decision of Substantially Equivalent on February 22, 2024, 216 days after the submission was received.
What is the product code of K232163?
The FDA product code is MQE – Needle, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6100.