DeviceClearance

Product code SCV— General, Plastic Surgery

Anovo Surgical System (6Ne)

Classification name
Modular Electromechanical Surgical System
Device class
Class 2
Regulation
21 CFR 878.4964
Advisory panel
General, Plastic Surgery
Total cleared
4
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SCV under 21 CFR 878.4964, via openFDA

Market context for product code SCV

FDA has cleared 4 devices under product code SCV between 2024 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SCV

Adverse events under product code SCV

product code SCV
Malfunction
608
Total
608

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code SCV

Data sourced from openFDA. This site is unofficial and independent of the FDA.