LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)— 510(k) K131234

Substantially Equivalent

Broncus Medical, Inc.

FDA 510(k) clearance K131234 for LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON), Substantially Equivalent on 2013-10-15. Applicant: Broncus Medical, Inc..

Clearance details

Applicant: Broncus Medical, Inc.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2013-05-01
Decision date: 2013-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.