← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OAB — Low Energy Direct Current Thermal Ablation System

Ablation of soft tissue

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4400
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K253826Galvanize Therapeutics, Inc. · 510k2026-05-07
K253198Angiodynamics · 510k2026-03-24
K242687AngioDynamics, Inc. · 510k2024-12-06
K240376Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 510k2024-10-04

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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