Aroa Biosurgery , Ltd. - FDA 510(k) Cleared Devices

Aroa Biosurgery, Ltd. is a medical device company specializing in soft tissue repair and regenerative healing products. The company operates with a manufacturing facility in Airport Oaks, New Zealand, and develops bioscaffold-based solutions for wound management and surgical reconstruction.

Aroa Biosurgery has received 7 FDA 510(k) clearances from 7 total submissions since its first clearance in 2018. The company's portfolio is dominated by General & Plastic Surgery devices, which account for 86% of submissions. The most recent clearance was issued in 2025, confirming the company's active regulatory status.

The company's cleared devices include restorative bioscaffolds, surgical soft tissue matrices, and combination cellular products designed for acute and chronic wound management, complex reconstruction, and hernia repair. These products leverage the proprietary AROA ECM platform technology to support regenerative healing across multiple surgical specialties.

Explore the complete list of device names, product codes, and individual clearance dates in the 510(k) database.