510(k) · Cleared
ClearedEndoFix™Tissue Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Softac Medical Technologies · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Aug 20, 2025 as substantially equivalent to K152524 (Cook Incorporated, 2015) and 1 other predicate after a 121-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Aug 20, 2025
- Review
- 121 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K963160 (1997). 12 ancestors in all, the oldest K873606 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK963160 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 1997
- 7 generations backK990687 HX-5/6-1 Endoscopic Clipping Device, Endoscopic ClipsOlympus Optical, Co. · 1999
- 6 generations backK013066 HX-5/6-1 Endoscopic Clipping DeviceOlympus America, Inc. · 2001 · Recalled
- 5 generations backK040148 Resolution Hemostasis Clipping DeviceBoston Scientific Corp · 2004 · Recalled
- 4 generations backK122660 Resolution Clip Model M00522600, M00522601, M00522602, M00522610…Boston Scientific Corporation · 2012
- 3 generations backK142973 Resolution ClipBoston Scientific Corporation · 2014
- 2 generations backK151802 Resolution ClipBoston Scientific Corporation · 2015
- 1 generation backK201808 X-Tack Endoscopic HeliX Tacking SystemApollo Endosurgery, Inc. · 2020 · Recalled
- This deviceK251229 EndoFix™Tissue Fixation SystemSoftac Medical Technologies · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963160 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 1997 | — |
| −7 | K990687 | HX-5/6-1 Endoscopic Clipping Device, Endoscopic Clips | Olympus Optical, Co. | 1999 | — |
| −6 | K013066 | HX-5/6-1 Endoscopic Clipping Device | Olympus America, Inc. | 2001 | 1 |
| −5 | K040148 | Resolution Hemostasis Clipping Device | Boston Scientific Corp | 2004 | 2 |
| −4 | K122660 | Resolution Clip Model M00522600, M00522601, M00522602, M00522610, M00522611… | Boston Scientific Corporation | 2012 | — |
| −3 | K142973 | Resolution Clip | Boston Scientific Corporation | 2014 | — |
| −2 | K151802 | Resolution Clip | Boston Scientific Corporation | 2015 | — |
| −1 | K201808 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | 2020 | 2 |
| 0 (this device) | K251229 | EndoFix™Tissue Fixation System | Softac Medical Technologies | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 FGE? 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 FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 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 |
|---|---|---|---|
| * | K152524 | Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable…Summary page 5…Endosurgery, Austin TX (currently Manufacturer: Cook Incorporated Boston Scientific Corp.) 510(k) Number: K152524 K201808 PKL- Hemorrhoidal ligator Product C… | 2015 |
| * | K201808 | X-Tack Endoscopic HeliX Tacking SystemSummary page 5…ufacturer: Cook Incorporated Boston Scientific Corp.) 510(k) Number: K152524 K201808 PKL- Hemorrhoidal ligator Product Code FGE- Biliary catheter and acc… | 2020 |
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 28 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 12 ancestors have a recall of any class.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, 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 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The EndoFix ™ Tissue Fixation System is an endoscopic tissue approximation system intended for anchoring the gallbladder to the stomach or duodenum to aid placement of a luminal apposing metal stent (LAMS) for EUS-guided gallbladder drainage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251229 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251229: EndoFix™Tissue Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251229
Report an extraction error
Are you the manufacturer?
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