DeviceClearance

Product code OAB— General, Plastic Surgery

NanoKnife System

Classification name
Low Energy Direct Current Thermal Ablation System
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
15
First cleared
Most recent

FDA classification definition

“Ablation of soft tissue”

— U.S. Food and Drug Administration, device classification record for product code OAB under 21 CFR 878.4400, via openFDA

Market context for product code OAB

FDA has cleared 15 devices under product code OAB between 2006 and 2026, filed by 9 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 OAB

Adverse events under product code OAB

product code OAB
Death
5
Total
5

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 OAB

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