FDA.report

510(k) K253354

Device
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
Applicant
Guangzhou Hehong Biotech Co., Ltd.
510(k) number
K253354
Product code
MQF
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-12
Date received
2025-09-30
Regulation
884.6110
Classification name
Catheter, Assisted Reproduction
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Yu Feng
Address
A Zone, 2/F, Bldg. A, Huazi Industrial Park, Shilou Town, Panyu District Guangzhou CN 511447 511447

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
06971855770957Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.2026-03-10
06971855770940Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.2026-03-10
06971855770933Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.2026-03-10
06971855770926Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.2026-03-10
06971855770919Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.2026-03-10
06971855770902Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.2026-03-10

Other 510(k) Records For Product Code MQF

510(k)DeviceApplicantDecision date
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 AB2025-07-23
K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)Shenzhen Vitavitro Biotech Co., Ltd.2024-08-16
K231730FemaSeed Intratubal InseminationFemasys, Inc.2023-09-22
K220010Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd.2022-12-16
K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsAllwin Medical Devices, Inc.2020-07-01
K192540Kitazato ET CathetersKitazato Corporation2020-05-01
K190522Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)Allwin Medical Devices, Inc.2019-11-14
K191015Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)Cook Incorporated2019-05-17
K180302Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing CatheterCook Incorporated2018-10-24
K173431Towako Transmyometrial Embryo Transfer SetWilliam A. Cook Australia Pty. , Ltd.2018-05-18
K173103Pivet and Soft-Pass Embryo Transfer Catheter SetsCook Incorporated2018-04-13
K173686Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer CatheterCook Incorporated2018-04-11
K172051Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide CatheterCook Incorporated2018-01-10
K172321Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination CathetersCook Incorporated2017-12-21
K163318Soules Intrauterine Insemination CatheterCook Incorporated2017-07-14