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Wallace Dual Lumen Oocyte Retrieval Sets

by Portex, Ltd.

510(k) K031622

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031622 Date26 Jun 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQE
FDA applicant
Portex , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.6100
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Wallace Dual Lumen Oocyte Retrieval Sets are needle-based devices used in assisted reproduction for the collection of oocytes from ovarian follicles. These devices are classified as Class II medical devices under FDA regulation 884.6100 with product code MQE.

The sets are sterile, single-use devices designed for ultrasound-guided transvaginal oocyte retrieval. They consist of a dual-lumen stainless steel needle attached to polyurethane tubing, available in 16 gauge or 17 gauge sizes with 33 cm length and 1 cm of echomarking at the distal tip, and are supplied in a sterile condition for single-use application.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Wallace Dual Lumen Oocyte Retrieval Set used for?

    The Wallace Dual Lumen Oocyte Retrieval Set is a needle-based device used in assisted reproduction for the collection of oocytes from ovarian follicles during ultrasound-guided transvaginal procedures.

  • How is the Wallace Dual Lumen Oocyte Retrieval Set supplied and is it reusable?

    The device is supplied sterile and is designed for single-use only; it is not intended for cleaning, sterilization, or reuse due to the risk of contamination and material degradation.

  • What sizes and specifications does the Wallace Dual Lumen Oocyte Retrieval Set come in?

    The set is available in 16 gauge or 17 gauge sizes, with a 33 cm length, dual-lumen stainless steel needle, polyurethane tubing, and 1 cm of echomarking at the distal tip for ultrasound visibility.