FDA-Device2022-02-09Class II
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.
FEMSelect Ltd
Hazard
Certain lots may not have been packaged wth the Channel Tube Limiter.
Sold states
US Nationwide distribution in the state of Georgia.
Affected count
141 units
Manufactured in
HaMa'ayan 2, First Floor, Modi'in, N/A, Israel
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0556-2022Don't want to check this manually?
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