510(k) · Cleared
ClearedSymani Surgical System
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 Sep 4, 2025 as substantially equivalent to K242368 (Medical Microinstruments, Inc., 2025) after a 111-day review. Its family tree reaches back 2 generations to 2024.
- Decided
- Sep 4, 2025
- Review
- 111 days
- Class
- Class II
- Product code
- SAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN230032 (2024). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K242368 | Symani Surgical System Our reading of the summary gave K242358, FDA’s number for Powered wheelchair (mobility robot) (M4, M4U) (Xsto Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Symani Surgical System”. | 2025 |
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 1 year and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K242368.
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, mouth, scalp, extremities, and in 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/K251510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251510: Symani 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/K251510
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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