About This 510(k) Submission
K253354 is an FDA 510(k) clearance for the Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C), a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Guangzhou Hehong Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 12, 2026, 135 days after receiving the submission on September 30, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.