Cleared Special

NICO TRIOwand

K162075 · Nico Corporation · General & Plastic Surgery

Aug 2016

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K162075 is an FDA 510(k) clearance for the NICO TRIOwand, 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 August 11, 2016, 15 days after receiving the submission on July 27, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K162075 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 27, 2016
Decision Date	August 11, 2016
Days to Decision	15 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
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).