510(k) · Cleared
ClearedMIRA 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
Cleared on Aug 20, 2026 as substantially equivalent to DEN230025 (Virtual Incision, 2024) after a 160-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Aug 20, 2026
- Review
- 160 days
- Class
- Class II
- Product code
- SAB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230025 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230025 MIRA Surgical SystemVirtual Incision · 2024
- This deviceK260817 MIRA Surgical SystemVirtual Incision · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230025 | MIRA Surgical System | Virtual Incision | 2024 | — |
| 0 (this device) | K260817 | MIRA Surgical System | Virtual Incision | 2026 | — |
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 SAB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN230025 | MIRA Surgical SystemSummary page 5…de: SAB Submission Type: Traditional 510(k) III. PEDICATE DEVICE INFORMATION Predicate Device: MIRA Surgical System (DEN230025) IV. DEVICE DESCRIPTION The MIRA Surgical System is a miniaturized robotic assisted surgery device consisting of an… | 2024 |
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?
- Its one ancestor has no recall.
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. 2026, 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 intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, dissect, and suture while maintaining hemostasis with electrocautery during manipulation of tissues. The device is indicated for mobilization of the colon during minimally invasive colectomy in adults at least 5'0" (1.52 m) tall and having a weight…
Read the full statement (163 words)
The MIRA Surgical System is a miniaturized robotic assisted surgery device intended to assist in the visualization of tissues and provide accurate and precise control of surgical instruments to grasp, retract, dissect, and suture while maintaining hemostasis with electrocautery during manipulation of tissues.
The device is indicated for mobilization of the colon during minimally invasive colectomy in adults at least 5'0" (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg).
The MIRA Surgical System is also indicated for minimally invasive benign (sub-) total hysterectomy with or without salpingectomy in adults with a uterine size not exceeding 12 cm longitudinally on imaging, at least 5'0" (1.52 m) tall and having a weight of at least 100 lbs (45.36 kg), and a BMI less than 40kg/m2.
It is for prescription use only and is to be used by trained physicians in any operating room environment in accordance with the representative surgical procedures listed in the MIRA Surgical System User Manual.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260817: MIRA Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260817
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026