510(k) K242043
K242043 is an FDA 510(k) premarket notification submitted by Gimbo Medical Technology Shenzhen Co., Ltd. for the device "Sperm Freezing Medium". The FDA issued a decision of Substantially Equivalent on January 8, 2025. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Gimbo Medical Technology Shenzhen Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 2025
- Date Received
- July 12, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type