# K251510: Symani Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Microinstruments, Inc.
- Decided: Sep 4, 2025 after 111 days
- Product code: SAQ (Electromechanical System For Open Microsurgery)
- Device class: 2
- Regulation: 21 CFR 878.4963
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN230032 (2024). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242368: Symani Surgical System, Medical Microinstruments, Inc. (2025). 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”. Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K251510
Methodology: https://510kreport.com/methodology