510(k) · Cleared
ClearedMUSE System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medigus, Ltd. · ODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Cleared on Jun 5, 2015 as substantially equivalent to K143634 (Medigus, Ltd., 2015) after a 51-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Jun 5, 2015
- Review
- 51 days
- Class
- Class II
- Product code
- ODE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K972679 (1997). 15 ancestors in all, the oldest K934738 (1994). No later device cites it as a predicate yet.
- Root · 8 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
- 7 generations backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
- 6 generations backK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
- 5 generations backK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
- 4 generations backK071651 Egs Serosafuse Implantable Fasteners, Associated Delivery Devices…Endogastric Solutions, Inc. · 2007
- 3 generations backK120299 SRS Endoscopic Stapling SystemMedigus, Ltd. · 2012
- 2 generations backK132151 SRS Endoscopic Stapling SystemMedigus, Ltd. · 2014
- 1 generation backK143634 MUSE SystemMedigus, Ltd. · 2015
- This deviceK151001 MUSE SystemMedigus, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K972679 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −7 | K980022 | Endopath Endoscopic Tissue Fastening System (Etfs) | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −6 | K994290 | Bard Endoscopic Suturing System | C.R. Bard, Inc. | 2000 | — |
| −5 | K062875 | Endogastric Stomaphyx Device and Accessories | Endogastric Solutions, Inc. | 2007 | — |
| −4 | K071651 | Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and… | Endogastric Solutions, Inc. | 2007 | — |
| −3 | K120299 | SRS Endoscopic Stapling System | Medigus, Ltd. | 2012 | — |
| −2 | K132151 | SRS Endoscopic Stapling System | Medigus, Ltd. | 2014 | — |
| −1 | K143634 | MUSE System | Medigus, Ltd. | 2015 | — |
| 0 (this device) | K151001 | MUSE System | Medigus, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 3 | 0 |
| 2007 | 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 ODE? 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 ODE device
- #1 K240879 EsophyX Z+ Device with SerosaFuse Fasteners…score 8.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K143634 | MUSE SystemSummary page 4…eflux Disease (GERD) 21 CFR 876.1500- Endoscope and Accessories Regulatory Class: II Product Code: ODE Special Controls: N/A III. PREDICATE DEVICE K143634 Medigus SRS Endoscopic Stapling System (Trade Name MUSE) This predicate has not been subject to a design-related recall. No r… | 2015 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 15 ancestors have a recall of any class.
How does its category compare?
All ODE devicesODE Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ODE
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ODE
51in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODE
No recall names ODE since 2007.
Adverse event reports per year · ODE
39in 2025
MAUDE reports naming product code ODE, 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 | 3 | 88 | 0 | 2 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 25 |
| 2011 | 0 | — | 0 | 28 |
| 2012 | 1 | — | 0 | 25 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 2 | — | 0 | 7 |
| 2015 | 3 | 51 | 0 | 5 |
| 2016 | 1 | — | 0 | 12 |
| 2017 | 2 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 2 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 39 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medigus Ultrasonic Surgical Endostapler (MUSETM) System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151001 · printed Nov 4, 2026
Cite this page
510(k) Report. “K151001: MUSE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K151001
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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