Cleared Traditional

VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)

K240307 · Shenzhen Vitavitro Biotech Co., Ltd. · Obstetrics & Gynecology
Aug 2024
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K240307 is an FDA 510(k) clearance for the VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH), a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Shenzhen Vitavitro Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 16, 2024, 196 days after receiving the submission on February 2, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.

Submission Details

510(k) Number K240307 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2024
Decision Date August 16, 2024
Days to Decision 196 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQF — Catheter, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6110

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