EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201

• K Number: K000950
• Device Name: EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
• Manufacturer: LABOTECT LABOR-TECHNIK GOTTINGEN
• Date Cleared: 2000-05-12 ( 50 days)
• Product Code: MQF
• Regulation Number: 884.6110

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 884.6110 Assisted reproduction catheters.

(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).

Summary

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