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510(k) K173865

trophon2 by Nanosonics Limited — Product Code OUJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2018
Date Received
December 20, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
Device Class
Class II
Regulation Number
892.1570
Review Panel
HO
Submission Type

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).

Other clearances by Nanosonics Limited

  • K253267 — CORIS System (March 5, 2026)
  • DEN240018 — CORIS System (March 19, 2025)
  • K241536 — trophon Wireless Ultrasound Probe Holder (September 27, 2024)
  • K103126 — TROPHON CHEMICAL INDICATOR (March 3, 2011)
  • K103059 — TROPHON (February 24, 2011)

Other clearances for product code OUJ

  • K250434 — trophon2 (August 5, 2025)
  • K241536 — trophon Wireless Ultrasound Probe Holder (September 27, 2024)
  • K103059 — TROPHON (February 24, 2011)