Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
FDA 510(k) clearance K233477 · decided 2024-07-01
Clearance details
- K-number
- K233477
- Device name
- Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)
- Applicant
- Shandong Wego Ruisheng Medical Device Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-10-26
- Decision date
- 2024-07-01
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- MQL
- Device class
- 2
- Regulation number
- 884.6180
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Weihai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.