TROPHON— 510(k) K103059

Name: FDA 510(k) clearance K103059
Creator: U.S. Food and Drug Administration
Published: 2011-02-24

Substantially Equivalent

Nanosonics Limited

FDA 510(k) clearance K103059 for TROPHON, Substantially Equivalent on 2011-02-24. Applicant: Nanosonics Limited. Device class: 2.

Clearance details

Applicant: Nanosonics Limited
Product code: Code OUJ
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 2010-10-15
Decision date: 2011-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, Nsw, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUJ

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K250434 — trophon22025-08-05
K241536 — trophon Wireless Ultrasound Probe Holder2024-09-27
K173865 — trophon22018-04-24

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K253267 — CORIS System2026-03-05
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K103126 — TROPHON CHEMICAL INDICATOR2011-03-03

Adverse events under product code OUJ

product code OUJ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K103059

K-number listed on FDA's recall record

Z-1602-2022 — NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037Class II·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20220525

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103059.

Data sourced from openFDA. This site is unofficial and independent of the FDA.