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Minvitro Embryo Transfer Catheters (ETCA23175 +5 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K253354
Identifiers
- 510(k) Number
- K253354 FDA 510(k)
- FDA Product Code
- MQF FDA 510(k)
- Models / Variants
- ETCA23175 FDA 510(k)ETCA23175-C FDA 510(k)ETCB20175 FDA 510(k)ETCB20175-C FDA 510(k)ETCB20175-ET FDA 510(k)ETCB20175-ET-C FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6110 FDA 510(k)
- Regulation Number
- 884.6110 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Minvitro Embryo Transfer Catheters (ETCA23175 +5 more) by Guangzhou Hehong Biotech Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 6 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253354 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Hehong Biotech Co., Ltd.
Sources (1)
- FDA 510(k) K253354 24 fields · synced Jun 19, 2026