SiteRite 9 Ultrasound System— 510(k) K231283

Name: FDA 510(k) clearance K231283
Creator: U.S. Food and Drug Administration
Published: 2023-09-11

Substantially Equivalent

Bard Access Systems, Inc. (C.R. Bard, Inc.)

FDA 510(k) clearance K231283 for SiteRite 9 Ultrasound System, Substantially Equivalent on 2023-09-11. Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.). Device class: 2.

Clearance details

Applicant: Bard Access Systems, Inc. (C.R. Bard, Inc.)
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2023-05-03
Decision date: 2023-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake Ciy,, UT, US

Download summary PDF View 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, 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 →

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