DeviceClearance

SONOSITE EDGE ULTRASOUND SYSTEM— 510(k) K113156

Substantially Equivalent

Sonosite,Inc.

FDA 510(k) clearance K113156 for SONOSITE EDGE ULTRASOUND SYSTEM, Substantially Equivalent on 2011-11-15. Applicant: Sonosite,Inc.. Device class: 2.

Clearance details

Applicant
Sonosite,Inc.
Product code
Code IYO
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bothell, WA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IYO

product code IYO
Malfunction
3,339
Total
3,339

Source: openFDA MAUDE database, through . 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 K113156

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113156.

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