510(k) · Cleared
ClearedSymani Surgical System (820-03830)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Microinstruments, Inc. · SAQ Electromechanical System For Open Microsurgery
Cleared on Jan 27, 2025 as substantially equivalent to DEN230032 (Mmi North America, Inc., 2024) after a 25-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jan 27, 2025
- Review
- 25 days
- Class
- Class II
- Product code
- SAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230032 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230032 Symani Surgical SystemMmi North America, Inc. · 2024
- This deviceK250014 Symani Surgical System (820-03830)Medical Microinstruments, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230032 | Symani Surgical System | Mmi North America, Inc. | 2024 | — |
| 0 (this device) | K250014 | Symani Surgical System (820-03830) | Medical Microinstruments, Inc. | 2025 | — |
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 SAQ? 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 SAQ device
- #1 K242368 Symani Surgical Systemscore 14.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | DEN230032 | Symani Surgical SystemSummary page 5…Product Code: SAQ Submission Type: Special 510(k) III. PREDICATE DEVICE INFORMATION: Predicate Device: Symani Surgical System, DEN230032 IV. DEVICE DESCRIPTION: Symani is designed to provide surgeons with increased precision while leveraging the surgeon’s own surg… | 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.
- 1 other device also cites its predicate DEN230032.
How does its category compare?
All SAQ devicesSAQ Electromechanical System For Open Microsurgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SAQ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SAQ
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SAQ
No recall names SAQ since 2007.
Adverse event reports per year · SAQ
No MAUDE report names SAQ 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 | 4 | 111 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Symani® Surgical System is intended for soft tissue manipulation to perform anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5 mm in open free-flap surgery of the breast and extremities and open lymphatic surgery of the extremities. The Symani® Surgical System is indicated for use during microsurgical procedures when use of a motion scaling function is deemed appropriate by the surgeon. The System is indicated for use in adults. It is intended to be used by trained physicians in an appropriate operating environment in accordance with the Instructions for Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250014 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250014: Symani Surgical System (820-03830).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250014
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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