510(k) K241454
K241454 is an FDA 510(k) premarket notification submitted by Guangzhou Hehong Biotech Co., Ltd. for the device "Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)". The FDA issued a decision of Substantially Equivalent on February 3, 2025. The device falls under product code MQK (Labware, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6160. Guangzhou Hehong Biotech Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2025
- Date Received
- May 22, 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