De Novo · Granted
GrantedSymani Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mmi North America, Inc. · SAQ Electromechanical System For Open Microsurgery
Granted on Apr 5, 2024 as a new device type through De Novo after a 346-day review. 4 later devices descend from it.
- Decided
- Apr 5, 2024
- Review
- 346 days
- Class
- Class II
- Product code
- SAQ
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN230032 Symani Surgical SystemMmi North America, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK242368 Symani Surgical SystemMedical Microinstruments, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252287 Symani Surgical SystemMedical Microinstruments, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK251510 Symani Surgical SystemMedical Microinstruments, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK250014 Symani Surgical System (820-03830)Medical Microinstruments, Inc. · 2025
Most influential descendants
Showing 4 of 4 · See all- K242368Symani Surgical SystemMedical Microinstruments, Inc. · 2025 · cites it directly2descendants
- K252287Symani Surgical SystemMedical Microinstruments, Inc. · 2025 · 2 generations on0descendants
- K251510Symani Surgical SystemMedical Microinstruments, Inc. · 2025 · 2 generations on0descendants
- K250014Symani Surgical System (820-03830)Medical Microinstruments, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230032 | Symani Surgical System | Mmi North America, Inc. | 2024 | — |
| +1 | K242368 | Symani Surgical System | Medical Microinstruments, Inc. | 2025 | — |
| +2 | K252287 | Symani Surgical System | Medical Microinstruments, Inc. | 2025 | — |
| +2 | K251510 | Symani Surgical System | Medical Microinstruments, Inc. | 2025 | — |
| +1 | K250014 | Symani Surgical System (820-03830) | Medical Microinstruments, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 4 | 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 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K242368 (Medical Microinstruments, Inc., 2025) has gone furthest, with 2 descendants of its own.
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. 2024, 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/DEN230032 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230032: Symani 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/DEN230032
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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