Panels › General, Plastic Surgery › Product code OCL · Class 2

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

Regulation 878.4400

0510(k)s in 12 months (54 all time)

0recalls in 12 months (17 all time)

17recalls that name a 510(k)

Top companies in OCL

Company	510(k)s	Recalls
AtriCure, Inc.	20	7
Medtronic	11	0
Ncontact Surgical, Inc.	6	0
Cardima, Inc.	2	2
MEDTRONIC ATS MEDICAL, INC.	0	4
Cryocath Technologies, Inc.	3	0
St Jude Medical	2	1
Endocare, Inc.	2	0
Endoscopic Technologies, Inc. D/B/A Estech	2	0
Medtronic Perfusion Systems	0	2

Decided	510(k)	Device and applicant	Code
Sep 20, 2001	K011988	SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C Cardiofocus, Inc.	OCL
Jun 15, 2001	K011040	CRYOCARE CARDIAC SURGICAL SYSTEM Endocare, Inc.	OCL
Feb 3, 1998	K974320	CRYOGEN CARDIAC CRYOSURGICAL SYSTEM Cryogen, Inc.	OCL
May 9, 1997	K970496	HEARTPORT MAZE SYSTEM: CRYOPROBE SET Heartport, Inc.	OCL

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