Cleared Traditional

trophon Wireless Ultrasound Probe Holder

K241536 · Nanosonics Limited · General Hospital
Sep 2024
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K241536 is an FDA 510(k) clearance for the trophon Wireless Ultrasound Probe Holder, a High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist (Class II — Special Controls, product code OUJ), submitted by Nanosonics Limited (Macquarie Park, AU). The FDA issued a Cleared decision on September 27, 2024, 120 days after receiving the submission on May 30, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number K241536 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2024
Decision Date September 27, 2024
Days to Decision 120 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).