MQE
- Product code
- MQE
- Device name
- Needle, Assisted Reproduction
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.6100
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 33 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253121 | 2026-06-15 | Gimbo Medical Technology Shenzhen Co.,… | Giftlife Single Lumen Oocyte Retrieval Needle, Giftl… | — |
| K240523 | 2024-11-15 | Shenzhen Vitavitro Biotech Co., Ltd. | VitaVitro® Single Lumen Oocyte Retrieval Needle (ORN… | |
| K232163 | 2024-02-22 | Zhejiang Horizon Medical Technology Co… | Lotus Single Lumen Ovum Aspiration Needle; Lotus Dou… |
Official FDA classification page: MQE
Classification and pathway per current FDA publications. Data from openFDA (CC0).