Identifiers
- 510(k) Number
- K242368 FDA 510(k)
- FDA Product Code
- SAQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4963 FDA 510(k)
- Regulation Number
- 878.4963 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Symani Surgical System is an electromechanical system for open microsurgery. It is a robotic technology designed for microsurgery and supermicrosurgery, featuring two tele-manipulated surgical arms engineered for precision in delicate procedures.
The device is supplied by Medical Microinstruments, Inc. and has received FDA 510(k) clearance under K242368. It is classified as a Class II device with product code SAQ and regulation number 878.4963, intended for use in general and plastic surgery settings.
Frequently asked questions
What is the Symani Surgical System used for?
The Symani Surgical System is designed for microsurgery and supermicrosurgery, providing precision in delicate open surgical procedures through its two tele-manipulated surgical arms.
How is the Symani Surgical System supplied and is it reusable?
The Symani Surgical System is supplied by Medical Microinstruments, Inc. as an electromechanical system; the provided data does not specify whether components are single-use or reusable, so reuse status cannot be determined from the information given.
What regulatory clearance does the Symani Surgical System have?
The Symani Surgical System has received FDA 510(k) clearance under submission number K242368 and is classified as a Class II device with product code SAQ.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Symani - MMI, MMI - Discover the future of Robotic Microsurgery, Symani Surgical System - Head and Neck Robotic Surgery, Symani Surgical System - Medical XPRT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242368 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Microinstruments, Inc
- FDA Applicant
- Medical Microinstruments, Inc.
Sources (1)
- FDA 510(k) K242368 24 fields · synced Sep 24, 2026