Cook Ultra Quiet Vacuum Pump & Regulator
FDA 510(k) K992070 · Cook Urological, Inc.
510(k) numberK992070
Submission
- Device name
- Cook Ultra Quiet Vacuum Pump & Regulator
- Applicant
- Cook Urological, Inc.
Spencer, IN, US - Received
- June 18, 1999
- Decision date
- October 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQG – Accessory, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6120
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code MQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261083 | Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum…MQG · Traditional | CooperSurgical, Inc. | 08/19/2026SE |
| K260194 | Vacuum Pump (Model: AD-VPUM-500)MQG · Traditional | Sheng Sheng Yi (Beijing) Technology Company… | 04/28/2026SE |
| K242684 | Harioculture TL-16 Time-lapse IncubatorMQG · Traditional | Hua Yue Medical Technology Co., Ltd. | 05/22/2025SE |
| K232493 | Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)MQG · Traditional | Wuhan Huchuang Union Technology Co., Ltd. | 05/07/2024SE |
| K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishMQG · Traditional | Genea Biomedx Pty, Ltd. | 06/07/2018SE |
| K173264 | EmbryoScope+MQG · Traditional | Vitrolife A/S | 05/11/2018SE |
| K180304 | Geri Embryo Incubator and Geri DishMQG · Special | Genea Biomedx Pty, Ltd. | 04/20/2018SE |
| K171736 | Geri Embryo Incubator and Geri DishMQG · Traditional | Genea Biomedx Pty, Ltd. | 11/15/2017SE |
| K160753 | COOK Vacuum PumpMQG · Traditional | William A. Cook Australia Pty. , Ltd. | 06/13/2017SE |
| K160504 | RI Witness Embryology Heated PlateMQG · Traditional | Research Instruments Limited | 07/18/2016SE |
More from Research Instruments Limited
| 510(k) | Device | Decision |
|---|---|---|
| K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)KNA · Traditional | 05/06/2011SE |
| K091767 | 3 Way Silicone Foley Balloon CatheterEZL · Traditional | 10/09/2009SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | 09/03/2009SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | 11/07/2008SE |
| K082536 | Cook Wire GuidesOCY · Traditional | 10/27/2008SE |
| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | 09/25/2008SE |
| K080525 | Cook Odyssey Holmium Laser System, Model 30WGEX · Traditional | 04/17/2008SE |
| K073496 | Optilite Holmium Laser FibersGEX · Traditional | 01/23/2008SE |
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access SheathFFS · Traditional | 11/20/2007SE |
| K061371 | Sydney Ivf Sperm Cryopreservation BufferMQL · Traditional | 08/17/2006SE |
Questions and answers
When was Cook Ultra Quiet Vacuum Pump & Regulator cleared by the FDA?
Cook Ultra Quiet Vacuum Pump & Regulator (K992070) received a 510(k) decision of Substantially Equivalent on October 27, 1999, 131 days after the submission was received.
What is the product code of K992070?
The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.