# K130059: Endofast Reliant SCP, Endofast Reliant Lap

- Pathway: 510(k) (Traditional)
- Applicant: Ibi Israel Biomedical Innovations, Ltd.
- Decided: Jul 29, 2013 after 200 days
- Product code: PBQ (Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931386 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080836: Modification to Endofast Reliant System, Endogun Medical Systems (2008) Summary page 2.
- K090470: Autosuture Protack; Tacker System; Absorbatack Fixation Devices, Covidien (2009) Summary page 2.

## Indications for 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.

Source page: https://510kreport.com/device/K130059
Methodology: https://510kreport.com/methodology