Cleared Traditional

TROPHON

K103059 · Nanosonics Limited · General Hospital
Feb 2011
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K103059 is an FDA 510(k) clearance for the TROPHON, a High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist (Class II — Special Controls, product code OUJ), submitted by Nanosonics Limited (Alexandria, Nsw, AU). The FDA issued a Cleared decision on February 24, 2011, 132 days after receiving the submission on October 15, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K103059 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2010
Decision Date February 24, 2011
Days to Decision 132 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).