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FDA 510(k)

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)

K-Number: K253354 · 2026-02-12

ApplicantGuangzhou Hehong Biotech Co., Ltd.
Decision Date2026-02-12
Product CodeMQF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) is a medical device manufactured by Guangzhou Hehong Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-02-12 under approval number K253354. 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 Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)?

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) is a medical device that received FDA 510(k) clearance on 2026-02-12. It is manufactured by Guangzhou Hehong Biotech Co., Ltd.. The 510(k) number is K253354.

When was Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) approved by the FDA?

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) received FDA 510(k) clearance on 2026-02-12, under approval number K253354.

What company makes Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)?

Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) is manufactured by Guangzhou Hehong Biotech Co., Ltd..

What is the FDA product code for Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)?

The FDA product code for Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) is MQF.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING NCT07396181 Standardization of Variable Conditions of Embryo Transfer Into the Uterine Cavity in the Procedure of Medically Assisted Procreation in Humans RECRUITING

Other Devices by Guangzhou Hehong Biotech Co., Ltd.

K241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)

Related Devices (Code: MQF)

K172321Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CathetersCook Incorporated K163318Soules Intrauterine Insemination CatheterCook Incorporated K162878Kitazato ET CathetersKitazato Corporation K162667Kitazato IUI CatheterKitazato Corporation K161547Transem and EchoGen Embryo Transfer CathetersOrigio A/S K162064CrossBay IVF Embryo Transfer Catheter SetCrossbay Medical, 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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