MQE — Needle, Assisted Reproduction Class II
FDA Device Classification
Classification Details
- Product Code
- MQE
- Device Class
- Class II
- Regulation Number
- 884.6100
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K240523 | shenzhen vitavitro biotech co | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® | November 15, 2024 |
| K232163 | zhejiang horizon medical technology co | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Ne | February 22, 2024 |
| K190590 | allwin medical devices | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double | November 25, 2019 |
| K191291 | coopersurgical | Wallace Dual Lumen Oocyte Recovery System | June 12, 2019 |
| K182959 | coopersurgical | Wallace Dual Lumen Oocyte Recovery System | May 10, 2019 |
| K171625 | willian a. cook australia pty | Single Lumen Ovum Aspiration Needles | January 12, 2018 |
| K171611 | william a. cook australia pty. | Double Lumen Ovum Aspiration Needles | December 15, 2017 |
| K172050 | vitrolife sweden | Follicle Aspiration Set, Reduced Single Lumen | November 21, 2017 |
| K162881 | kitazato corporation | Kitazato OPU Needles | July 11, 2017 |
| K161970 | vitrolife sweden | Follicle Aspiration Set | June 14, 2017 |
| K141365 | william a. cook australia pty. | OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN | August 7, 2014 |
| K112462 | kitazato medical co | KITAZATO OPU NEEDLE | November 26, 2012 |
| K082727 | vitrolife sweden | FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN | February 6, 2009 |
| K051742 | inntec | OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH | October 7, 2005 |
| K032208 | fertility technology resources | MONA LISA ASPIRATION NEEDLE | December 9, 2003 |
| K032015 | rocket medical | EMBRYON ULTRASOUND NEEDLE GUIDE | August 8, 2003 |
| K031622 | portex | WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS | June 26, 2003 |
| K023930 | coopersurgical | COOPERSURGICAL OOCYTE RECOVERY NEEDLES | January 22, 2003 |
| K013497 | gynetics medical products | FAS SET #4551 | November 9, 2001 |
| K012068 | sims portex | WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEON | August 3, 2001 |