510(k) · Cleared
ClearedEndofast Reliant SCP, Endofast Reliant Lap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibi Israel Biomedical Innovations, Ltd. · PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Cleared on Jul 29, 2013 as substantially equivalent to K080836 (Endogun Medical Systems, 2008) and 1 other predicate after a 200-day review. Its family tree reaches back 9 generations to 1993.
- Decided
- Jul 29, 2013
- Review
- 200 days
- Class
- Class II
- Product code
- PBQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K931386 (1993). 23 ancestors in all, the oldest K922916 (1992). No later device cites it as a predicate yet.
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 5 generations between
- 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 2 generations backK060329 Endofast Reliant SystemEndogun Medical Systems · 2006
- 1 generation backK080836 Modification to Endofast Reliant SystemEndogun Medical Systems · 2008
- This deviceK130059 Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd. · 2013
Show all 9 generations
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 8 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 7 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 6 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 5 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 4 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 2 generations backK060329 Endofast Reliant SystemEndogun Medical Systems · 2006
- 1 generation backK080836 Modification to Endofast Reliant SystemEndogun Medical Systems · 2008
- This deviceK130059 Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −8 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −7 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −6 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −5 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −4 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −3 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −2 | K060329 | Endofast Reliant System | Endogun Medical Systems | 2006 | — |
| −1 | K080836 | Modification to Endofast Reliant System | Endogun Medical Systems | 2008 | — |
| 0 (this device) | K130059 | Endofast Reliant SCP, Endofast Reliant Lap | Ibi Israel Biomedical Innovations, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PBQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PBQ device
- #1 K260380 Menditscore 12.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080836 | Modification to Endofast Reliant SystemSummary page 2…Product Code: OTO Regulation No: 878.3300 Class: 2 Classification Panel: Obstetrics/Gynecology Predicate Devices: EndoFast ReliantTM System-K080836 AutosutureTM TACKER - K090470 Device Description: The EndoFast ReliantTM SCP (Sacrocolpopexy) is a sterile, single use system… | 2008 |
| * | K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation DevicesSummary page 2…egulation No: 878.3300 Class: 2 Classification Panel: Obstetrics/Gynecology Predicate Devices: EndoFast ReliantTM System-K080836 AutosutureTM TACKER - K090470 Device Description: The EndoFast ReliantTM SCP (Sacrocolpopexy) is a sterile, single use system which consists of the followin… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 23 ancestors have a recall of any class.
How does its category compare?
All PBQ devicesPBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PBQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PBQ
Too few PBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PBQ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBQ
5in 2025
MAUDE reports naming product code PBQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130059: Endofast Reliant SCP, Endofast Reliant Lap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130059
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026