WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

• K Number: K000628
• Device Name: WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733
• Manufacturer: SIMS PORTEX LTD.
• Date Cleared: 2000-03-13 ( 18 days)
• Product Code: MQE
• Regulation Number: 884.6100

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

§ 884.6100 Assisted reproduction needles.

(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(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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