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Falcon IVF Four Well Plate

by Becton Dickinson Labware

510(k) K991249

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 NumberK991249 Date5 May 1999ClearedStatusActive

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  • Withdrawn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
MQK
Device Class
Class II
Regulation
21 CFR Part 884.6160
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The Falcon IVF Four Well Plate is a piece of labware designed for assisted reproduction laboratories. It is intended for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization, gamete intrafallopian transfer, or other reproduction procedures.

This single-use, sterile, and non-pyrogenic device is manufactured from polystyrene. It features four wells, each with a 1.39 cm2 area and 1.8 mL volume, and includes a specialized lid that allows access to two wells while keeping the others covered. The device has received FDA 510(k) clearance.

Other devices from Becton Dickinson Labware

Questions

AI-generated answers, 25 Sep 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 intended use of the Falcon IVF Four Well Plate?

    This device is designed for use in assisted reproduction laboratories. It is used for the preparation, storage, manipulation, or transfer of human gametes or embryos during procedures such as in vitro fertilization or gamete intrafallopian transfer.

  • Is the Falcon IVF Four Well Plate reusable?

    No, this device is intended for single-use only. It is manufactured as a sterile and non-pyrogenic product to ensure the integrity of sensitive reproductive samples, and it should be disposed of after the initial procedure.

  • What are the physical dimensions of the wells?

    Each of the four wells on the plate features a surface area of 1.39 cm2 and a volume capacity of 1.8 mL, providing sufficient space for the handling of gametes and embryos.

  • Does the plate include any special features for laboratory access?

    Yes, the plate includes a specialized lid design. This lid allows for access to two wells at a time while keeping the remaining two wells covered, which helps maintain a controlled environment for the samples.

  • Has this device received regulatory clearance?

    Yes, the Falcon IVF Four Well Plate has received FDA 510(k) clearance under the Obstetrics/Gynecology advisory committee.