Data / Medical devices / United States / Arobella Medical, LLC
Arobella Medical, LLC: FDA-registered device maker in Minnetonka, MN, United States, 3 510(k) clearances
Arobella Medical, LLC is registered with the FDA (registration 3007225330) in Minnetonka, MN, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 16, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007225330
- Address
- 111 Cheshire Lane, Suite 100, Minnetonka, MN, United States, 55305
- Owner or operator
- Arobella Medical, LLC (10024460)
- Roles
- Manufacturer
- First device listed
- February 3, 2008
- Registered through
- 2026
- Brand names listed
- Qoustic Wound Therapy System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Ultrasonic Surgical | LFL | U | Manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Manufacturer | accessdata.fda.gov |
| Wound Cleaner, Ultrasound | NRB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2014 | K131096 | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | NRB | Substantially Equivalent | Arobella Medical, LLC | accessdata.fda.gov |
| June 19, 2009 | K091038 | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM | NRB | Substantially Equivalent | Arobella Medical, LLC | accessdata.fda.gov |
| January 3, 2007 | K062544 | AR1000 ULTRASONIC WOUND THERAPY SYSTEM | LFL | Substantially Equivalent | Arobella Medical, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 5, 2012 | 63808 | Class II | Terminated | Arobella 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 t | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Ultrasonic Surgical
- All makers of Wound Cleaner, Ultrasound
- All makers of Lavage, Jet
Updated May 16, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.