Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter – Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter – Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter – Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet – 180 mm (REF 17510); EmbryoCath Stylet – 230 mm (REF 17511) (K243373)
Description
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511) by Vitrolife Sweden AB, an FDA 510(k) cleared obstetrics/gynecology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243373
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter – Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter – Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter – Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet – 180 mm (REF 17510); EmbryoCath Stylet – 230 mm (REF 17511) (K243373) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K162878 | Kitazato ET Catheters | Kitazato Corporation | 2017 |
Trace the full predicate network for K243373
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.