Product code SAQ— General, Plastic Surgery

Symani Surgical System

Classification name: Electromechanical System For Open Microsurgery
Device class: Class 2
Regulation: 21 CFR 878.4963
Advisory panel: General, Plastic Surgery
Total cleared: 5
First cleared: 2024-04-05
Most recent: 2025-11-10

FDA classification definition

“An electromechanical system for open microsurgery is a software-controlled electromechanical system with bedside human/device interfaces and without an integrated visualization system which allows a qualified user to perform surgical techniques during open mircosurgical procedures using surgical instruments attached to an electromechanical arm.”
— U.S. Food and Drug Administration, device classification record for product code SAQ under 21 CFR 878.4963, via openFDA

Market context for product code SAQ

FDA has cleared 5 devices under product code SAQ between 2024 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20254 clearances
20241 clearance

Top applicants under product code SAQ

Medical Microinstruments, Inc.4 clearances
Mmi North America, Inc.1 clearance

Recent clearances under product code SAQ

K252287 — Symani Surgical SystemMedical Microinstruments, Inc.·2025-11-10
K251510 — Symani Surgical SystemMedical Microinstruments, Inc.·2025-09-04
K242368 — Symani Surgical SystemMedical Microinstruments, Inc.·2025-02-07
K250014 — Symani Surgical System (820-03830)Medical Microinstruments, Inc.·2025-01-27
DEN230032 — Symani Surgical SystemMmi North America, Inc.·2024-04-05

Data sourced from openFDA. This site is unofficial and independent of the FDA.