510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242368Substantially Equivalent

Symani Surgical System

Medical Microinstruments, Inc., Pisa, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K242368 is the FDA 510(k) clearance record for Symani Surgical System, a class II device, cleared for Medical Microinstruments, 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 4 510(k) clearances for Medical Microinstruments, Inc., from to . As of , FDA records show no recalls naming K242368.

Clearance record

Decision date
Received
(182 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
Medical Microinstruments, Inc. Via Egidio Giannessi 54, Pisa, IT
510(k) summary
Summary PDF
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