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FDA 510(k)

IUI CATHETERS

K-Number: K112396 · 2012-11-02

ApplicantKitazato Medical Co., Ltd.
Decision Date2012-11-02
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IUI CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Medical Co., Ltd.. It received FDA 510(k) clearance on 2012-11-02 under 510(k) number K112396. The device is classified under product code MQF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IUI CATHETERS?

IUI CATHETERS is a medical device that received FDA 510(k) clearance on 2012-11-02. The listed applicant is Kitazato Medical Co., Ltd.. The 510(k) number is K112396.

When did IUI CATHETERS receive FDA 510(k) clearance?

IUI CATHETERS received FDA 510(k) clearance on 2012-11-02, under 510(k) number K112396.

Who is the listed applicant for IUI CATHETERS?

The FDA 510(k) record lists Kitazato Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IUI CATHETERS?

The FDA product code for IUI CATHETERS is MQF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kitazato Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131491KITAZATO IUI CATHETERK112462KITAZATO OPU NEEDLE

Related Devices (Code: MQF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)Guangzhou Hehong Biotech Co., Ltd.K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)Vitrolife Sweden ABK240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)Shenzhen Vitavitro Biotech Co., Ltd.K231730FemaSeed Intratubal InseminationFemasys, Inc.K220010Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd.K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsAllwin Medical Devices, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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