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FDA PRODUCT CODE · CLASS II

SAQ — Electromechanical System For Open Microsurgery

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4963
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K252287Medical Microinstruments, Inc. · 510k2025-11-10
K251510Medical Microinstruments, Inc. · 510k2025-09-04
K242368Medical Microinstruments, Inc. · 510k2025-02-07
K250014Medical Microinstruments, Inc. · 510k2025-01-27

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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