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EnPlace Refill Kit

FEMSELECT LTD · Model FG-0004-R · UDI-DI 17290017082056

PBQ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Refill Kit for EnPlace. EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue Anchor to the ligaments of the pelvic floor. The Anchors are pre-loaded inside the device Shaft and are ready for use. Refill Kit should be used with Finger Guide supplied with the EnPlace kit, as a guide channel for better handling of EnPlace.

Recalls

Date	Firm	Reason
2021-12-13	FEMSelect Ltd	Certain lots may not have been packaged wth the Channel Tube Limiter.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.