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FDA 510(k)

Kitazato ET Catheters

K-Number: K162878 · 2017-07-13

ApplicantKitazato Corporation
Decision Date2017-07-13
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Kitazato ET Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Corporation. It received FDA 510(k) clearance on 2017-07-13 under 510(k) number K162878. 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 Kitazato ET Catheters?

Kitazato ET Catheters is a medical device that received FDA 510(k) clearance on 2017-07-13. The listed applicant is Kitazato Corporation. The 510(k) number is K162878.

When did Kitazato ET Catheters receive FDA 510(k) clearance?

Kitazato ET Catheters received FDA 510(k) clearance on 2017-07-13, under 510(k) number K162878.

Who is the listed applicant for Kitazato ET Catheters?

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

What is the FDA product code for Kitazato ET Catheters?

The FDA product code for Kitazato ET Catheters is MQF.

Other records listing Kitazato Corporation 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.

K260248Ultra-Fast WarmK251305Ultra-Fast Vitri; Ultra-Fast WarmK200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAK192845Sperm Freeze, Sperm FridgeK192540Kitazato ET Catheters

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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

View on FDA Database →

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

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