FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
K Number: K240523
·
Decision Nov 15, 2024
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
5
Review Days
266
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Basic Information
- Device Name
- VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)
- K Number
- K240523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6100
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Vitavitro Biotech Co., Ltd.
- Date Received
- February 23, 2024
- Decision Date
- November 15, 2024
- Product Code
- MQE
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQE | Needle, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQE), ordered by most recent decision date.
Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Wallace Dual Lumen Oocyte Recovery System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Wallace Dual Lumen Oocyte Recovery System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Single Lumen Ovum Aspiration Needles
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Shenzhen Vitavitro Biotech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K240307 | VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) | Aug 16, 2024 | Substantially Equivalent |
| K212410 | VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium | Feb 1, 2022 | Substantially Equivalent |
| K200408 | VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium | Oct 16, 2020 | Substantially Equivalent |
| K191063 | 1-Step Culture Medium | Aug 23, 2019 | Substantially Equivalent |