Ovum Pick-Up Aspiration Needles
FDA 510(k) K983593 · Cook Ob/Gyn
510(k) numberK983593
Submission
- Device name
- Ovum Pick-Up Aspiration Needles
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- October 13, 1998
- Decision date
- January 21, 1999
- 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 |
|---|---|---|
| K062438 | Bakri Postpartum Balloon, Model J-SOS-100500KNA · Traditional | 10/27/2006SE |
| K030441 | Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw KitMQL · Traditional | 08/29/2003SE |
| K023850 | Sydney Ivf Embryo Biopsy MediumMQL · Traditional | 01/22/2003SE |
| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | 04/17/2002SE |
| K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…MQL · Traditional | 09/18/2000SE |
| K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient KitMQL · Traditional | 09/13/2000SE |
| K983595 | Transmyometrial Embryo Transfer SetMQF · Traditional | 02/08/1999SE |
| K983596 | Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes…MQH · Traditional | 02/05/1999SE |
| K983642 | Cook Mini-IncubatorMQG · Traditional | 02/01/1999SE |
| K983594 | Embryo Transfer Catheters/SetsMQF · Traditional | 12/21/1998SE |
Questions and answers
When was Ovum Pick-Up Aspiration Needles cleared by the FDA?
Ovum Pick-Up Aspiration Needles (K983593) received a 510(k) decision of Substantially Equivalent on January 21, 1999, 100 days after the submission was received.
What is the product code of K983593?
The FDA product code is MQE – Needle, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6100.