Embryo Transfer Catheter - Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- EmbryoCath Embryo Transfer Catheter – Pre-curved 230mm EUDAMED
- Device Name
- EmbryoCath Embryo Transfer Catheter EUDAMED
- Model / Reference
- 17500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350025912509 EUDAMED
- Basic UDI-DI
- 735002591ACGDU EUDAMED
- 510(k) Number
- K243373 FDA 510(k)
- FDA Product Code
- MQF FDA 510(k)
- EMDN Code
- U08020102 CATHETERS FOR EMBRYO TRANSFER EUDAMED
- Models / Variants
- Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500) FDA 510(k)EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6110 FDA 510(k)
- Regulation Number
- 884.6110 FDA 510(k)
- Market of Registration
- Sweden EUDAMED
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The EmbryoCath Embryo Transfer Catheter Assortment consists of single-use catheters designed for embryo transfer in assisted reproductive procedures. These devices facilitate the placement of embryos into the uterine cavity during in vitro fertilization (IVF) cycles, ensuring precise and controlled delivery.
The assortment includes pre-curved and straight malleable catheters in lengths of 180 mm and 230 mm, paired with corresponding stylets for shaping. Supplied sterile and intended for single-use, these catheters comply with FDA 510(k) and MDR regulations. They are classified as Class II medical devices and are regulated under the European Medical Device Regulation (EU MDR) and FDA’s Traditional 510(k) pathway, with advisory review by the Obstetrics/Gynecology committee.
Frequently asked questions
What are the key differences between the pre-curved and straight malleable catheters in this assortment, and how do I choose between them?
The EmbryoCath assortment includes a pre-curved catheter (REF 17500, 230 mm) designed for a fixed, angled shape to match specific anatomical preferences, and straight malleable catheters (REF 17501, 180 mm; REF 17502, 230 mm) that can be manually bent to fit individual patient anatomy. Pre-curved catheters are ideal when a consistent angle is preferred, while malleable catheters offer flexibility to adjust the catheter’s shape during the procedure. The choice depends on clinician preference and patient-specific needs, such as uterine cavity shape or ease of navigation.
Are the stylets included in this assortment reusable, or are they also single-use like the catheters?
The stylets (REF 17510 for 180 mm and REF 17511 for 230 mm) are intended for single-use only, just like the catheters. They are supplied sterile and paired specifically with their corresponding catheter lengths to ensure proper shaping and functionality during embryo transfer procedures.
What lengths are available for the catheters and stylets, and how might I determine which length to use?
The assortment includes catheters and stylets in two lengths: 180 mm (REF 17501 catheter, REF 17510 stylet) and 230 mm (REF 17500 pre-curved catheter, REF 17502 straight malleable catheter, REF 17511 stylet). The choice depends on patient anatomy, clinician preference, and the depth required to reach the uterine cavity. Shorter lengths (180 mm) may suffice for patients with shallower uterine cavities, while longer lengths (230 mm) provide additional reach for deeper placements or anatomical variations.
How should these catheters be stored, and what precautions should be taken to maintain sterility?
The catheters are supplied sterile and should be stored in their original, sealed packaging to preserve sterility. They must remain unopened until immediately before use. Storage should follow manufacturer guidelines, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by keeping the packaging intact until the catheter is ready for use in the procedure.
What regulatory pathways have been followed for this device, and how does that affect its use in clinical settings?
This device has undergone FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR), confirming its safety and performance for embryo transfer procedures. The FDA’s Obstetrics/Gynecology advisory committee reviewed it under the Traditional 510(k) pathway, ensuring it meets established standards for assisted reproduction catheters. Clinicians can rely on its regulatory approvals when selecting this device for IVF embryo transfer procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243373 | Class II | Active |
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Manufacturer
- Manufacturer
- Vitrolife Sweden AB
Sources (2)
- FDA 510(k) K243373 24 fields · synced Oct 6, 2026
- EUDAMED 12e0a61b-2a4d-42ae-9d02-155b0618d5e2 61 fields · synced Jul 28, 2026