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FDA 510(k)

AS 1000 ULTRASOUND WOUND THERAPY SYSTEM

K-Number: K091038 · 2009-06-19

ApplicantArobella Medical, LLC
Decision Date2009-06-19
Product CodeNRB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AS 1000 ULTRASOUND WOUND THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arobella Medical, LLC. It received FDA 510(k) clearance on 2009-06-19 under 510(k) number K091038. 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 AS 1000 ULTRASOUND WOUND THERAPY SYSTEM?

AS 1000 ULTRASOUND WOUND THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-19. The listed applicant is Arobella Medical, LLC. The 510(k) number is K091038.

When did AS 1000 ULTRASOUND WOUND THERAPY SYSTEM receive FDA 510(k) clearance?

AS 1000 ULTRASOUND WOUND THERAPY SYSTEM received FDA 510(k) clearance on 2009-06-19, under 510(k) number K091038.

Who is the listed applicant for AS 1000 ULTRASOUND WOUND THERAPY SYSTEM?

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

What is the FDA product code for AS 1000 ULTRASOUND WOUND THERAPY SYSTEM?

The FDA product code for AS 1000 ULTRASOUND WOUND THERAPY SYSTEM is NRB.

Related Clinical Trials

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.

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Other records listing Arobella Medical, LLC 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.

K062544AR1000 ULTRASONIC WOUND THERAPY SYSTEM

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.K112782MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIESMisonix, Inc.K050129CELLERATION 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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