Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LungPoint Virtual Bronchoscopic Navigation (VBN) Software

K-Number: K260009 · 2026-04-24

ApplicantBroncus Medical, Inc.
Decision Date2026-04-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LungPoint Virtual Bronchoscopic Navigation (VBN) Software is a medical device manufactured by Broncus Medical, Inc.. It received FDA 510(k) clearance on 2026-04-24 under approval number K260009. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LungPoint Virtual Bronchoscopic Navigation (VBN) Software?

LungPoint Virtual Bronchoscopic Navigation (VBN) Software is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Broncus Medical, Inc.. The 510(k) number is K260009.

When was LungPoint Virtual Bronchoscopic Navigation (VBN) Software approved by the FDA?

LungPoint Virtual Bronchoscopic Navigation (VBN) Software received FDA 510(k) clearance on 2026-04-24, under approval number K260009.

What company makes LungPoint Virtual Bronchoscopic Navigation (VBN) Software?

LungPoint Virtual Bronchoscopic Navigation (VBN) Software is manufactured by Broncus Medical, Inc..

What is the FDA product code for LungPoint Virtual Bronchoscopic Navigation (VBN) Software?

The FDA product code for LungPoint Virtual Bronchoscopic Navigation (VBN) Software is LLZ.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT03768648 Cognition and MRI Markers in MS Patients With Aubagio® Treatment COMPLETED NCT07599826 Active vs. Passive VR During Office-based ENT Procedures NOT_YET_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025)

Other Devices by Broncus Medical, Inc.

K183240Empower RF Catheter K200702EasyPath RF Introducer Sheath K232601BroncTru™ Transbronchial Access Tool K232038BioStar Single Use Transbronchial Aspiration Needle

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑