510(k) K253121
- Device
- Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd.
- 510(k) number
- K253121
- Product code
- MQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-15
- Date received
- 2025-09-25
- Regulation
- 884.6100
- Classification name
- Needle, Assisted Reproduction
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Guo Leo
- Address
- 601, Bldg. C5, # 459 Qiaokai Rd., Fenghuang St. Guangming District Shezhen CN 518107 518107
FDA Registration Numbers#
- 3003995932
- 3005580113
- 3008456389
- 3005987240
- 1650907
- 9610632
- 3009217531
- 3034286426
- 3005136445
- 8043478
- 1820334
- 9611680
- 3006405073
- 9612445
- 3003775072
- 3014755376
- 3014295858
- 9617744
- 3015136743
- 1216677
- 1450908
- 3017896194
- 3008876063
- 3015140190
- 3010155661
- 3009756327
- 9680654
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MQE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240523 | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) | Shenzhen Vitavitro Biotech Co., Ltd. | 2024-11-15 |
| K232163 | Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle | Zhejiang Horizon Medical Technology Co., Ltd. | 2024-02-22 |
| K190590 | Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) | Allwin Medical Devices, Inc. | 2019-11-25 |
| K191291 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019-06-12 |
| K182959 | Wallace Dual Lumen Oocyte Recovery System | CooperSurgical, Inc. | 2019-05-10 |
| K171625 | Single Lumen Ovum Aspiration Needles | Willian A. Cook Australia Pty, Ltd. | 2018-01-12 |
| K171611 | Double Lumen Ovum Aspiration Needles | William A. Cook Australia Pty. , Ltd. | 2017-12-15 |
| K172050 | Follicle Aspiration Set, Reduced Single Lumen | Vitrolife Sweden AB | 2017-11-21 |
| K162881 | Kitazato OPU Needles | Kitazato Corporation | 2017-07-11 |
| K161970 | Follicle Aspiration Set | Vitrolife Sweden AB | 2017-06-14 |
| K141365 | OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN | William A. Cook Australia Pty. , Ltd. | 2014-08-07 |
| K112462 | KITAZATO OPU NEEDLE | Kitazato Medical Co., Ltd. | 2012-11-26 |
| K082727 | FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN | Vitrolife Sweden AB | 2009-02-06 |
| K051742 | OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH | Inntec, Inc. | 2005-10-07 |
| K032208 | MONA LISA ASPIRATION NEEDLE | Fertility Technology Resources, Inc. | 2003-12-09 |