Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S
FDA 510(k) K012068 · Sims Portex , Ltd.
510(k) numberK012068
Submission
- Device name
- Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S
- Applicant
- Sims Portex , Ltd.
Hythe, Kent, GB - Received
- July 2, 2001
- Decision date
- August 3, 2001
- 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 |
| 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 |
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| K994275 | Sims Portex Anesthesia CatheterFRN · Traditional | 02/22/2000SE |
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Questions and answers
When was Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S cleared by the FDA?
Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S, Meons 1733S (K012068) received a 510(k) decision of Substantially Equivalent on August 3, 2001, 32 days after the submission was received.
What is the product code of K012068?
The FDA product code is MQE – Needle, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6100.