De Novo · Granted
GrantedMIRA Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Virtual Incision · SAB Table Mounted Miniaturized Electromechanical Surgical System
Granted on Feb 23, 2024 as a new device type through De Novo after a 318-day review. 1 later device descends from it.
- Decided
- Feb 23, 2024
- Review
- 318 days
- Class
- Class II
- Product code
- SAB
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN230025 MIRA Surgical SystemVirtual Incision · 2024
- Descendant · cites it directly · 0 of its ownK260817 MIRA Surgical SystemVirtual Incision · 2026
Most influential descendants
Showing 1 of 1 · See all- K260817MIRA Surgical SystemVirtual Incision · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230025 | MIRA Surgical System | Virtual Incision | 2024 | — |
| +1 | K260817 | MIRA Surgical System | Virtual Incision | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 SAB? 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 SAB device
- #1 K260817 MIRA Surgical Systemscore 11.9 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260817 | MIRA Surgical System | 2026 | 0 |
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?
- Of its descendants, K260817 (Virtual Incision, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All SAB devicesSAB Table Mounted Miniaturized Electromechanical Surgical System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SAB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SAB
Too few SAB 510(k)s in any year since 2007 to give a median.
Recalls per year · SAB
No recall names SAB since 2007.
Adverse event reports per year · SAB
No MAUDE report names SAB since 2007.
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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MIRA Surgical System is a miniaturized robotic assisted surgery device indicated for the mobilization of the colon in adults at least 5’0” (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg) who are undergoing minimally invasive colectomy procedures.
It is intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, and dissect while maintaining hemostasis with electrocautery during manipulation of tissues.
It is for prescription use only and is to be used by trained physicians in any operating room environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230025 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230025: MIRA Surgical System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230025
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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