# DEN230032: Symani Surgical System

- Pathway: De Novo (Direct)
- Applicant: Mmi North America, Inc.
- Decided: Apr 5, 2024 after 346 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K242368: Symani Surgical System (2025), 2 descendants of its own
- K252287: Symani Surgical System (2025), 0 descendants of its own
- K251510: Symani Surgical System (2025), 0 descendants of its own
- K250014: Symani Surgical System (820-03830) (2025), 0 descendants of its own

## 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 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

Source page: https://510kreport.com/device/DEN230032
Methodology: https://510kreport.com/methodology