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

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240307

by Shenzhen Vitavitro Bio-Tech Co., Ltd.

Identifiers

510(k) Number
K240307 FDA 510(k)
FDA Product Code
MQF FDA 510(k)
Models / Variants
Models ET-S FDA 510(k)
ET-SI FDA 510(k)
ET-A FDA 510(k)
ET-I FDA 510(k)
ET-IH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.6110 FDA 510(k)
Regulation Number
884.6110 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a catheter for assisted reproduction, specifically an embryo transfer catheter used in procedures such as in vitro fertilization (IVF) and gamete intrafallopian transfer (GIFT). It is designed to transfer embryos into the uterine cavity with minimal trauma, featuring soft and skin-friendly materials, a soft tip, and a slim inner diameter to reduce media usage.

The catheter is available in multiple models (ET-S, ET-SI, ET-A, ET-I, ET-IH) with or without an echotip and depth marks for accurate positioning and ultrasound visibility. It is supplied as a single-use device, authorized under FDA 510(k) clearance K240307, product code MQF, and classified as a Class II device under regulation 884.6110 for obstetrics/gynecology use.

Frequently asked questions

What is the VitaVitro Embryo Transfer Catheter used for?

The VitaVitro Embryo Transfer Catheter is used to transfer embryos into the uterine cavity during assisted reproduction procedures such as in vitro fertilization (IVF) and gamete intrafallopian transfer (GIFT), designed to minimize trauma with a soft tip and slim inner diameter.

Is the VitaVitro Embryo Transfer Catheter reusable or single-use?

The VitaVitro Embryo Transfer Catheter is supplied as a single-use device, meaning it is intended for one procedure only and should not be reprocessed or reused to ensure patient safety and device integrity.

What models are available for the VitaVitro Embryo Transfer Catheter and what features do they include?

The catheter is available in models ET-S, ET-SI, ET-A, ET-I, and ET-IH, which may include an echotip for ultrasound visibility and depth marks to assist with accurate positioning during embryo transfer procedures.

How is the VitaVitro Embryo Transfer Catheter supplied and stored?

The device is supplied as a single-use catheter, typically packaged sterile for immediate use; storage should follow standard medical device guidelines in a clean, dry environment until the expiration date indicated on the label.

What regulatory pathway was used for the VitaVitro Embryo Transfer Catheter?

The VitaVitro Embryo Transfer Catheter received authorization through the FDA 510(k) clearance process under submission number K240307, with product code MQF and classification as a Class II device under regulation 884.6110 for obstetrics/gynecology use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Embryo Transfer Catheter - VitaVitro Biotech, VitaVitro Embryo Transfer Catheter (Models ET-S… - FDA.report, VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Vitavitro Bio-Tech Co., Ltd.
FDA Applicant
Shenzhen Vitavitro Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K240307 24 fields · synced Sep 26, 2026