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510(k) Data Aggregation
K Number
K130059Device Name
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
Manufacturer
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD.
Date Cleared
2013-07-29
(200 days)
Product Code
PBQ, OTO
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.
The EndoFast Reliant™ LAP is indicated for fixation of surgical prosthetic material to tissues for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.
Device Description
The EndoFast Reliant™ SCP (Sacrocolpopexy) is a sterile, single use system which consists of the following parts:
- 3 metal Fixation Devices; each preloaded with a spider fastener composed of . metal and includes the MRI Safety Information that is stated in the labeling.
- . Plastic Handle; connects to the Fixation Device.
- . Surgical mesh composed of monofilament polypropylene material; cut in a rectangular shape of 8x20cm.
The device is introduced through a 5mm trocar in a laparoscopic approach. The mesh is attached to the vaginal vault and the vagina is pulled towards the posterior pelvic bony part. The other end of the mesh is attached to the promontorium, using two fixation points, to restore the normal anatomical position of the uterus and cervix.
The EndoFast Reliant™ LAP (Laparoscopic) is a sterile, single use system which consists of the following parts:
- 3 metal Fixation Devices, each preloaded with a spider fastener composed of . metal and include the MRI Safety Information that is stated in the labeling.
- Plastic Handle; connects to the Fixation Device. .
The fasteners are introduced through a 5mm trocar in laparoscopic procedures.
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