Cleared Special

NICO Myriad

K182340 · Nico Corporation · Obstetrics & Gynecology

Sep 2018

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K182340 is an FDA 510(k) clearance for the NICO Myriad, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Nico Corporation (Indianapolis, US). The FDA issued a Cleared decision on September 20, 2018, 23 days after receiving the submission on August 28, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K182340 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2018
Decision Date	September 20, 2018
Days to Decision	23 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).