Cleared Traditional

trophon2

K173865 · Nanosonics Limited · General Hospital
Apr 2018
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K173865 is an FDA 510(k) clearance for the trophon2, a High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist (Class II — Special Controls, product code OUJ), submitted by Nanosonics Limited (Lane Cove, AU). The FDA issued a Cleared decision on April 24, 2018, 125 days after receiving the submission on December 20, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K173865 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2017
Decision Date April 24, 2018
Days to Decision 125 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code OUJ — High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1570
Definition To Provide High Level Disinfection Of Ultrasound Transducers. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).