510(k) · Cleared
ClearedEndofast Reliant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endogun Medical Systems · FTL Mesh, Surgical, Polymeric
Cleared on Sep 11, 2006 as substantially equivalent to K003949 (A & A Medical, Inc., 2001) and 1 other predicate after a 214-day review. Its family tree reaches back 7 generations to 1993. 2 later devices descend from it.
- Decided
- Sep 11, 2006
- Review
- 214 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931386 (1993). 14 ancestors in all, the oldest K922916 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 6 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 5 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 4 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 3 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 2 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 1 generation backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- This deviceK060329 Endofast Reliant SystemEndogun Medical Systems · 2006
- Descendant · cites it directly · 1 of its ownK080836 Modification to Endofast Reliant SystemEndogun Medical Systems · 2008
- Descendant · 2 generations on · 0 of its ownK130059 Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −6 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −5 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −4 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −3 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −2 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −1 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K060329 | Endofast Reliant System | Endogun Medical Systems | 2006 | — |
| +1 | K080836 | Modification to Endofast Reliant System | Endogun Medical Systems | 2008 | — |
| +2 | 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 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 |
|---|---|---|---|
| * | K003949 | Tacker, Model R65-933Summary page 2…minimally invasive procedures Predicate Device: The predicate device for the Fixation Device is: A & A Tacker Endoscopic Stapler (K003949). The predicate device for the surgical Mesh is AMS Large Pore Polypropylene Mesh (K0… | 2001 |
| * | K033636 | Ams Large Pore Polypropylene MeshSummary page 2…Endoscopic Stapler (K003949). The predicate device for the surgical Mesh is AMS Large Pore Polypropylene Mesh (K033636). Performance Data The Fixation Device and Fastener were tested for Insertion force, Fatigue testing, Dynamic grip strength, Re… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080836 | Modification to Endofast Reliant System | 2008 | 1 |
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 13 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K080836 (Endogun Medical Systems, 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EndoFast Reliant System is indicated for fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K060329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060329: Endofast Reliant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060329
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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