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

Modular Electromechanical Surgical System

21 CFR 878.4964 / General, Plastic Surgery
FDA source (opens on fda.gov)

SCV is the FDA product code for Modular Electromechanical Surgical System, a class II device type, regulated under 21 CFR 878.4964. FDA's definition for this code reads: "A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
SCV
Device name
Modular Electromechanical Surgical System
FDA definition
A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.
Regulation
21 CFR 878.4964
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
4
Ingested recalls
1

Clearances, product code SCV

By decision year
4 clearances under product code SCV with a decision year between 2024 and 2026, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SCV by decision year
YearClearances
20241
20252
20261

Applicants with the most clearances

Product code SCV
Applicants holding the most 510(k) clearances under product code SCV
ApplicantClearances
CMR Surgical Inc.2
Medtronic, Inc.1
Momentis Surgical Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order