OCLClass II

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

21 CFR 878.4400 / General, Plastic Surgery

OCL is the FDA product code for Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue". As of 2026-09-10, FDA records hold 54 510(k) clearances under this code, the most recent dated 2025-07-24, and 17 recalls.

Classification record

Product code: OCL
Device name: Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
FDA definition: Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac 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: 54
Ingested recalls: 17

Clearances, product code OCL

By decision year

54 clearances under product code OCL with a decision year between 1997 and 2025, 2012 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code OCL by decision year
Year	Clearances
1997	1
1998	1
2001	2
2002	2
2003	1
2004	2
2005	1
2006	5
2007	3
2008	5
2009	2
2010	2
2011	2
2012	6
2013	2
2014	1
2017	1
2018	2
2019	6
2020	1
2021	2
2022	2
2024	1
2025	1

Applicants with the most clearances

Product code OCL

Applicants holding the most 510(k) clearances under product code OCL
Applicant	Clearances
AtriCure, Inc.	20
Medtronic, Inc.	13
Ncontact Surgical, Inc.	6
Medtronic CryoCath LP	3
Cardima, Inc.	2
Varian Medical Systems, Inc.	2
Endoscopic Technologies, Inc. D/B/A Estech	2
Abbott Medical	2
CardioFocus, Inc.	1
Cryocor, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order