510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Arobella Medical, LLC

Minnetonka, MN, US

AROBELLA MEDICAL, LLC appears in FDA device records in Minnetonka, MN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Arobella Medical, LLC between 2007 and 2014. The busiest year on record is 2007, with 1. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Arobella Medical, LLC, by decision year
YearClearances
20071
20091
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K131096AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEMNRBSubstantially Equivalent
K091038AS 1000 ULTRASOUND WOUND THERAPY SYSTEMNRBSubstantially Equivalent
K062544AR1000 ULTRASONIC WOUND THERAPY SYSTEMLFLSubstantially Equivalent

Registered establishments

FDA registered establishments for Arobella Medical, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30072253303007225330AROBELLA MEDICAL, LLC111 Cheshire Lane, Suite 100, Minnetonka, MN 55305 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0534-2013Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain