Kitazato OPU Needles
FDA 510(k) K162881 · Kitazato Corporation
510(k) numberK162881
Submission
- Device name
- Kitazato OPU Needles
- Applicant
- Kitazato Corporation
Tokyo, JP - Received
- October 14, 2016
- Decision date
- July 11, 2017
- 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
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| 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 |
| K161970 | Follicle Aspiration SetMQE · Traditional | Vitrolife Sweden AB | 06/14/2017SE |
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Questions and answers
When was Kitazato OPU Needles cleared by the FDA?
Kitazato OPU Needles (K162881) received a 510(k) decision of Substantially Equivalent on July 11, 2017, 270 days after the submission was received.
What is the product code of K162881?
The FDA product code is MQE – Needle, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6100.