FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium
K Number: K240149
·
Decision Jun 13, 2024
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
7
Review Days
146
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Basic Information
- Device Name
- Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium
- K Number
- K240149
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd.
- Date Received
- January 19, 2024
- Decision Date
- June 13, 2024
- Product Code
- MQL
- 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 |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQL), ordered by most recent decision date.
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Other Clearances by Gimbo Medical Technology Shenzhen Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253121 | Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval Needle | Jun 15, 2026 | Substantially Equivalent |
| K242043 | Sperm Freezing Medium | Jan 8, 2025 | Substantially Equivalent |
| K242968 | Giftlife® Single-Step Medium Plus | Nov 22, 2024 | Substantially Equivalent |
| K240002 | G-Vitri Vitrification Straw | Jun 14, 2024 | Substantially Equivalent |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | May 10, 2024 | Substantially Equivalent |
| K232942 | G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media | Jan 30, 2024 | Substantially Equivalent |