EnPlace Refill Kit

Primary DI
17290017082056
Brand
EnPlace Refill Kit
Company
FEMSELECT LTD
Model
FG-0004-R
Catalog number
FG-0004-R
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.
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBQFixation, Non-Absorbable Or Absorbable, For Pelvic Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBQFixation, Non-Absorbable Or Absorbable, For Pelvic UseObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160569000NeuGuidePop Medical Solutions2016-07-06PBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290017082056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729001708205617290017082056

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue/mesh anchor, bioabsorbableA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-215-940-8178debbie@femselect.com

Regulatory Flags#

DUNS number
600628181
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017082028EnPlaceFG-00001-02FG-00001-022022-06-19
17290017082025EnPlaceFG-00001-02FG-00001-022022-06-19
07290017082004NeuGuideâ„¢FG0001FG00012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019174219Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174226Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174233Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174240Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174257Mendit Retriver Universal SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174431Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174448Mendit Single Applicator SetESCALA MEDICAL LTDPBQ2026-03-10
07290019174455Mendit securement element setESCALA MEDICAL LTDPBQ2026-03-10
07290019174097Mendit applicator set ESCALA MEDICAL LTDPBQ2024-06-05
07290019174103Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174110Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174127Mendit Applicator SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174134Mendit Applicator SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174141Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174158Mendit Applicator SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174165Mendit Reload SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174172Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174189Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174196Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174202Mendit Retriever SetESCALA MEDICAL LTDPBQ2024-06-05
07290019174035Mendit Applicator SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174042Mendit Retriever SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174059Mendit Reload SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174400Mendit Applicator SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174417Mendit Retriever SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174424Mendit Reload SetESCALA MEDICAL LTDPBQ2023-10-23
07290019174004APYX Applicator SetESCALA MEDICAL LTDPBQ2023-08-06
07290019174028Mendit Reload SetESCALA MEDICAL LTDPBQ2023-06-25
07290019174011APYX Retriever SetESCALA MEDICAL LTDPBQ2022-11-06
07290019174066APYX Applicator SetESCALA MEDICAL LTDPBQ2022-11-03