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FDA 510(k)

MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES

K-Number: K112782 · 2011-12-01

ApplicantMisonix, Inc.
Decision Date2011-12-01
Product CodeNRB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Misonix, Inc.. It received FDA 510(k) clearance on 2011-12-01 under 510(k) number K112782. The device is classified under product code NRB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES?

MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2011-12-01. The listed applicant is Misonix, Inc.. The 510(k) number is K112782.

When did MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2011-12-01, under 510(k) number K112782.

Who is the listed applicant for MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES?

The FDA 510(k) record lists Misonix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES?

The FDA product code for MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES is NRB.

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Other records listing Misonix, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221235neXus Ultrasonic Surgical Aspirator SystemK212060neXus Ultrasonic Surgical Aspirator SystemK190160neXus Ultrasonic Surgical Aspirator SystemK123980SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIESK070779SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEMK070313MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM

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Related Devices (Code: NRB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162721Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel ApplicatorAlliqua Biomedical, Inc.K123980SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIESMisonix, Inc.K122246MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12Celleration, Inc.K091038AS 1000 ULTRASOUND WOUND THERAPY SYSTEMArobella Medical, LLCK050129CELLERATION MIST THERAPY SYSTEM 5.1Celleration, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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