510(k) K241341
K241341 is an FDA 510(k) premarket notification submitted by Fujifilm Irvine Scientific for the device "cryo-GO Vitrification Device". The FDA issued a decision of Substantially Equivalent on September 26, 2024. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Fujifilm Irvine Scientific has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2024
- Date Received
- May 13, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Labware, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6160
- Review Panel
- OB
- Submission Type