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

Low Energy Direct Current Thermal Ablation System

21 CFR 878.4400 / General, Plastic Surgery
FDA source (opens on fda.gov)

OAB is the FDA product code for Low Energy Direct Current Thermal Ablation System, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "Ablation of soft tissue". As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
OAB
Device name
Low Energy Direct Current Thermal Ablation System
FDA definition
Ablation of soft tissue
Regulation
21 CFR 878.4400
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
Yes
Ingested clearances
15
Ingested recalls
4

Clearances, product code OAB

By decision year
15 clearances under product code OAB with a decision year between 2006 and 2026, 2024 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code OAB by decision year
YearClearances
20061
20082
20111
20151
20191
20221
20231
20244
20263

Applicants with the most clearances

Product code OAB
Applicants holding the most 510(k) clearances under product code OAB
ApplicantClearances
Boston Scientific Corporation5
Galvanize Therapeutics3
Oncobionics, Inc.2
Hangzhou Ruidi Biotechnology, Ltd.1
Oncobionic Incorporated1
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.1
US Medical Innovations, LLC1
Zhejiang Curaway Medical Technology Co., Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order