EnPlace Refill Kit

Basic Information

• Brand Name: EnPlace Refill Kit
• Primary DI: 17290017082056
• Version / Model: FG-0004-R
• Catalog Number: FG-0004-R
• Company Name: FEMSELECT LTD
• Labeler DUNS: 600628181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-08
• Public Version: 1
• Public Version Date: 2026-01-16
• Public Version Status: New
• Public Device Record Key: 767957e9-8c96-439b-a0d0-8d08cc684e6b

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PBQ	Fixation, Non-Absorbable Or Absorbable, For Pelvic Use	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45027	Soft-tissue/mesh anchor, bioabsorbable	A bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290017082056	GS1
Package	17290017082056	GS1	Master Box	3	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K160569	000