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Kitazato IUI Catheter

by Kitazato Medical Co., Ltd.

510(k) K131491

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK131491 Date11 Sep 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
MQF
Device Class
Class II
Regulation
21 CFR Part 884.6110
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Kitazato IUI Catheter is a catheter for assisted reproduction, specifically designed for intrauterine insemination procedures. It is classified as a Class II medical device under product code MQF and regulation number 884.6110, with FDA 510(k) clearance under K131491, determined to be substantially equivalent to a predicate device.

The device is supplied by Kitazato Medical Co., Ltd. and is intended for use in obstetrics and gynecology settings. It is available in multiple rigidity levels and two different lengths to accommodate clinical preferences and patient needs, as indicated in the manufacturer's specifications.

Other devices from Kitazato Medical Co., Ltd.

Questions

AI-generated answers, 24 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 Kitazato IUI Catheter used for?

    The Kitazato IUI Catheter is designed for intrauterine insemination procedures in assisted reproduction, specifically to facilitate the placement of sperm into the uterine cavity during fertility treatments.

  • How is the Kitazato IUI Catheter supplied and what are its available options?

    The device is supplied by Kitazato Medical Co., Ltd. and is available in multiple rigidity levels and two different lengths to accommodate varying clinical preferences and patient anatomical needs, as specified by the manufacturer.

  • Is the Kitazato IUI Catheter intended for single-use or reuse?

    While the device data does not explicitly state reusability, as a catheter for intrauterine insemination in a sterile OB/GYN setting, it is intended for single-use to maintain sterility and prevent cross-contamination, consistent with standard clinical practice for such devices.

  • What regulatory pathway was used for the Kitazato IUI Catheter?

    The Kitazato IUI Catheter received FDA 510(k) clearance under K131491, demonstrating substantial equivalence to a predicate device, and is classified as a Class II medical device under product code MQF and regulation 884.6110.