FLEX Microwave Ablation System And Accessories

System, Ablation, Microwave And Accessories

NEUWAVE MEDICAL, INC.

The following data is part of a premarket notification filed by Neuwave Medical, Inc. with the FDA for Flex Microwave Ablation System And Accessories.

Pre-market Notification Details

• Device ID: K163118
• 510k Number: K163118
• Device Name: FLEX Microwave Ablation System And Accessories
• Classification: System, Ablation, Microwave And Accessories
• Applicant: NEUWAVE MEDICAL, INC. 3529 ANDERSON STREET Madison, WI 53704
• Contact: Dan Kosednar
• Correspondent: Dan Kosednar; NEUWAVE MEDICAL, INC. 3529 ANDERSON STREET Madison, WI 53704
• Product Code: NEY
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-08
• Decision Date: 2017-03-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00853719006302	K163118	000
00853719006326	K163118	000
00853719006319	K163118	000
00818913020189	K163118	000
00818913020172	K163118	000
00818913020158	K163118	000
00818913020073	K163118	000
00818913020196	K163118	000