Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)— 510(k) K253354
Substantially EquivalentGuangzhou Hehong Biotech Co., Ltd.
FDA 510(k) clearance K253354 for Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C), Substantially Equivalent on 2026-02-12. Applicant: Guangzhou Hehong Biotech Co., Ltd.. Device class: 2.
Summary
Guangzhou Hehong Biotech's Minvitro Embryo Transfer Catheters list six designations, from ETCA23175 to ETCB20175-ET-C. They're filed under product code MQF, assisted reproduction catheter, and the record doesn't say how the six differ.
Class II, 21 CFR 884.6110. Obstetrics/Gynecology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Guangzhou Hehong Biotech filed from Guangzhou, China. Review took 135 calendar days (September 30, 2025 to February 12, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Guangzhou Hehong Biotech Co., Ltd.
- Product code
- Product code MQF
- Device class
- Class 2
- Regulation
- 21 CFR 884.6110
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code MQF
view all- K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500) +4 more
- K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
- K231730 — FemaSeed Intratubal Insemination
- K220010 — Daylily Single Use Sterile Embryo Transfer Catheter
- K200248 — Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
More clearances from Guangzhou Hehong Biotech Co., Ltd.
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