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

Table Mounted Miniaturized Electromechanical Surgical System

21 CFR 878.4962 / General, Plastic Surgery
FDA source (opens on fda.gov)

SAB is the FDA product code for Table Mounted Miniaturized Electromechanical Surgical System, a class II device type, regulated under 21 CFR 878.4962. FDA's definition for this code reads: "A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
SAB
Device name
Table Mounted Miniaturized Electromechanical Surgical System
FDA definition
A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical device’s miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms
Regulation
21 CFR 878.4962
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code SAB

By decision year
2 clearances under product code SAB with a decision year between 2024 and 2026, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SAB by decision year
YearClearances
20241
20261

Applicants with the most clearances

Product code SAB
Applicants holding the most 510(k) clearances under product code SAB
ApplicantClearances
Virtual Incision1
Virtual Incision Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code