# K252287: Symani Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Microinstruments, Inc.
- Decided: Nov 10, 2025 after 110 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) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K252287
Methodology: https://510kreport.com/methodology