SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES— 510(k) K123980

Substantially Equivalent

Misonix, Inc.

FDA 510(k) clearance K123980 for SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES, Substantially Equivalent on 2013-03-05. Applicant: Misonix, Inc..

Clearance details

Applicant: Misonix, Inc.
Product code: Code NRB
Advisory panel: General, Plastic Surgery
Date received: 2012-12-26
Decision date: 2013-03-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Farmingdale, NY, US

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Adverse events under product code NRB

product code NRB

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 →

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