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510(k) DEN230032

Symani Surgical System by Mmi North America, Inc. — Product Code SAQ

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 5, 2024
Date Received
April 25, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromechanical System For Open Microsurgery
Device Class
Class II
Regulation Number
878.4963
Review Panel
SU
Submission Type

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.

Other clearances for product code SAQ

  • K252287 — Symani Surgical System (November 10, 2025)
  • K251510 — Symani Surgical System (September 4, 2025)
  • K242368 — Symani Surgical System (February 7, 2025)
  • K250014 — Symani Surgical System (820-03830) (January 27, 2025)