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 Nov 10, 2025 as substantially equivalent to K242368 (Medical Microinstruments, Inc., 2025) after a 110-day review. Its family tree reaches back 2 generations to 2024.
- Decided
- Nov 10, 2025
- Review
- 110 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 SystemSummary page 5…uct Code: SAQ Submission Type: Traditional 510(k) III. PREDICATE DEVICE INFORMATION: Predicate Device: Symani Surgical System, K242368 IV. DEVICE DESCRIPTION Symani is designed to provide surgeons with increased precision while leveraging the surgeon’s own surgi… | 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 indicated for soft tissue manipulation in open microsurgical procedures to perform:
• Anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5mm in open free-flap surgery of the breast, mouth, scalp, and extremities and in open lymphatic surgery of the extremities.
• Dissection of soft tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252287: Symani Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252287
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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