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510(k) K150993

NICO TRIOwand by Nico Corporation — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2015
Date Received
April 15, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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).

Other clearances by Nico Corporation

  • K232567 — Myriad SPECTRA Light Source (March 14, 2024)
  • K191599 — NICO Myriad NOVUS (September 13, 2019)
  • K182340 — NICO Myriad (September 20, 2018)
  • K172433 — NICO BrainPath (September 7, 2017)
  • K161307 — NICO Myriad (December 21, 2016)
  • K162075 — NICO TRIOwand (August 11, 2016)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (June 12, 2015)
  • K120691 — BRAIN PORT (June 5, 2012)

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