510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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DEN230032Unknown

Symani Surgical System

Mmi North America, Inc., Ponte Vedra FL / Direct, Unknown
FDA source (opens on fda.gov)

DEN230032 is the FDA 510(k) clearance record for Symani Surgical System, a class II device, cleared for Mmi North America, Inc. on under FDA product code SAQ (Electromechanical System For Open Microsurgery). FDA's definition for product code SAQ reads: "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...". FDA records list one 510(k) clearance for Mmi North America, Inc. As of , FDA records show no recalls naming DEN230032.

Clearance record

Decision date
Received
(346 days to decision)
Product code
SAQ Electromechanical System For Open Microsurgery
Regulation
21 CFR 878.4963
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Mmi North America, Inc. 344 Ponte Vedra Blvd., Ponte Vedra FL
Third party review
No

Clearances, product code SAQ

Trailing 12 months
1 clearance under product code SAQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAQ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260