AR1000 ULTRASONIC WOUND THERAPY SYSTEM— 510(k) K062544

Clearance details

Applicant

Arobella Medical, LLC

Product code

Code LFL

Device class

Unclassified

Advisory panel

Unknown

Date received

2006-08-30

Decision date

2007-01-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carmel, IN, US

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• K241700 — Tenex 2nd Generation System2024-11-18

• K131096 — AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM2014-05-16
• K091038 — AS 1000 ULTRASOUND WOUND THERAPY SYSTEM2009-06-19

Death

29

Injury

1,046

Malfunction

21,642

Total

22,717

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 →

• Z-0534-2013 — 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 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.Class II·Terminated·Arobella Medical, LLC·20121105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062544.