Prana Surgical

Company overview

Prana Surgical develops minimally invasive surgical technology in Houston, Texas. Formerly known as Prana Thoracic, the company combines CT-guided targeting, surgical access tools and bipolar electrosurgical instrumentation in the Prana System.

FDA cleared the Prana System under K253405 on April 1, 2026. The company plans a controlled U.S. clinical introduction and is evaluating suspicious pulmonary nodule applications in an Australian first-in-human study. Those specific lung applications remain investigational and are distinct from the device’s general electrosurgical use.

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Products & regulatory status How does MedTechIndex get this information?

Summary

FDA cleared the Prana System under K253405 on April 1, 2026. Specific pulmonary nodule applications remain investigational, and the company describes a controlled U.S. clinical introduction rather than broad routine availability. ^[9][8][5]

Regulatory snapshot How to read this snapshot

U.S. FDA

1

510(k) clearances

0

De Novo grants

0

PMA approvals

0

Recall events

Latest recorded source review: 2026-10-30.

Scope: selected product families.

Commercial portfolio snapshot

Controlled U.S. clinical introduction is planned.

Products with unconfirmed commercial availability

Image-guided electrosurgical system

Prana System ↗

CT-guided targeting, access tools and bipolar electrosurgery for controlled tissue removal and bleeding control. ^[11][9][8]

FDA 510(k)-cleared · K253405

Controlled U.S. clinical introduction planned; pulmonary nodule applications remain investigational.