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Sources: EU EUDAMED, US FDA
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Country: Israel
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FEMSelect Ltd.
Manufacturer
🇮🇱 Israel
FEMSelect Ltd
FDA registration
FEMSelect Ltd·1 product·🇮🇱 Israel
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.
FDA Enforcement
Class II
·Ongoing·FEMSelect Ltd·February 9, 2022