510(k) K253354 ยท MQF Catheter, Assisted Reproduction
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
| Applicant | Guangzhou Hehong Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Feb 12, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253354
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.