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FDA PRODUCT CODE · CLASS II

OCL — Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4400
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K252056AtriCure, Inc. · 510k2025-07-24

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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