Wallace Oocyte Retrieval SET-16G, Model MEONS1633; Wallace Oocyte Retrieval SET-17G, Model MEONS1733
FDA 510(k) K000628 · Sims Portex , Ltd.
510(k) numberK000628
Submission
- Device name
- Wallace Oocyte Retrieval SET-16G, Model MEONS1633; Wallace Oocyte Retrieval SET-17G, Model MEONS1733
- Applicant
- Sims Portex , Ltd.
Hythe, Kent, GB - Received
- February 24, 2000
- Decision date
- March 13, 2000
- 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 |
More from Kitazato Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K012277 | Portex Ring Pessary Pvc-Non Sterile; Portex Ring Pessary Polythene- Non SterileHHW · Traditional | 02/11/2002SE |
| K012068 | Wallace Oocyte Retrieval Sets 16G, Wallace Oocyte Retrieval Set 17G, Models Meons 1633S…MQE · Traditional | 08/03/2001SE |
| K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro…FMI · Traditional | 07/12/2001SE |
| K002201 | Electrostatic Hydrophobic Breathing FilterCAH · Traditional | 02/05/2001SE |
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| K001555 | Suresample-Wallace Endometrial Sampler, Endo 26HHK · Traditional | 08/02/2000SE |
| K001318 | CPAP System, Model 102001BYE · Traditional | 07/20/2000SE |
| K993619 | Csecure Combined Spinal/Epidural Anesthesia System with LockBSP · Traditional | 04/28/2000SE |
| K994275 | Sims Portex Anesthesia CatheterFRN · Traditional | 02/22/2000SE |
| K991861 | 1ST Response Infant Manual Resuscitator, Bag Resevoir, 1ST Response Pediatric Manual…BTM · Traditional | 01/18/2000SE |
Questions and answers
When was Wallace Oocyte Retrieval SET-16G, Model MEONS1633; Wallace Oocyte Retrieval SET-17G, Model MEONS1733 cleared by the FDA?
Wallace Oocyte Retrieval SET-16G, Model MEONS1633; Wallace Oocyte Retrieval SET-17G, Model MEONS1733 (K000628) received a 510(k) decision of Substantially Equivalent on March 13, 2000, 18 days after the submission was received.
What is the product code of K000628?
The FDA product code is MQE – Needle, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6100.