Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
FDA 510(k) clearance K242089 · decided 2025-04-10
Clearance details
- K-number
- K242089
- Device name
- Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
- Applicant
- Jiangsu Ruifuda Medical Device Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-07-17
- Decision date
- 2025-04-10
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Lianyungang, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.