Double Lumen Ovum Aspiration Needles
FDA 510(k) K171611 · William A. Cook Australia Pty. , Ltd.
510(k) numberK171611
Submission
- Device name
- Double Lumen Ovum Aspiration Needles
- Applicant
- William A. Cook Australia Pty. , Ltd.
Eight Mile Plains, AU - Received
- June 1, 2017
- Decision date
- December 15, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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|---|---|---|---|
| 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 |
| 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 |
| 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 |
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| K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…MQL · Special | 01/27/2016SE |
| K151367 | Sydney IVF HyaluronidaseMQL · Traditional | 01/27/2016SE |
| K152782 | Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf SpermientMQL · Special | 12/21/2015SE |
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Questions and answers
When was Double Lumen Ovum Aspiration Needles cleared by the FDA?
Double Lumen Ovum Aspiration Needles (K171611) received a 510(k) decision of Substantially Equivalent on December 15, 2017, 197 days after the submission was received.
What is the product code of K171611?
The FDA product code is MQE – Needle, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6100.