Cleared Traditional

Minvitro? Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

K241454 · Guangzhou Hehong Biotech Co., Ltd. · Obstetrics & Gynecology

Feb 2025

Decision

257d

Days

Class 2

Risk

About This 510(k) Submission

K241454 is an FDA 510(k) clearance for the Minvitro? Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP), a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Guangzhou Hehong Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 3, 2025, 257 days after receiving the submission on May 22, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.

Submission Details

510(k) Number	K241454 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2024
Decision Date	February 03, 2025
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF