ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2

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

ATRICURE, INC.

The following data is part of a premarket notification filed by Atricure, Inc. with the FDA for Atricure Bipolar System Including Isolator Synergy Dual Electrode Clamps Model Oll2, Osl2, Emr2, Eml2.

Pre-market Notification Details

• Device ID: K101174
• 510k Number: K101174
• Device Name: ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
• Classification: Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
• Applicant: ATRICURE, INC. 6217 CENTER PARK DRIVE West Chester, OH 45069
• Contact: James Lucky
• Correspondent: James Lucky; ATRICURE, INC. 6217 CENTER PARK DRIVE West Chester, OH 45069
• Product Code: OCL
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-04-27
• Decision Date: 2010-11-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00818354010824	K101174	000
00818354010756	K101174	000
30840143902387	K101174	000
30840143902257	K101174	000