K253354
- 510(k) number
- K253354
- Device name
- Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
- Applicant
- Guangzhou Hehong Biotech Co., Ltd. CN
- Product code
- MQF — Catheter, Assisted Reproduction
- Decision date
- 2026-02-12
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253354.pdf
Official FDA record: K253354
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.