NICO Myriad

Electrosurgical, Cutting & Coagulation & Accessories

NICO CORPORATION

The following data is part of a premarket notification filed by Nico Corporation with the FDA for Nico Myriad.

Pre-market Notification Details

• Device ID: K161307
• 510k Number: K161307
• Device Name: NICO Myriad
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: NICO CORPORATION 250 EAST 96TH STREET SUITE 125 Indianapolis, IN 46240
• Contact: Sean Spence
• Correspondent: Sean Spence; NICO CORPORATION 250 E. 96th Street, Suite 125 Indianapolis, IN 46240
• Product Code: GEI
• Subsequent Product Code: ERL
• Subsequent Product Code: HBC
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-05-10
• Decision Date: 2016-12-21
• Summary: summary