510(k) K241454

Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) by Guangzhou Hehong Biotech Co., Ltd. — Product Code MQK

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