DeviceClearance

Product code OMT— General, Plastic Surgery

BIO-SEAL LUNG BIOPSY TRACT SYSTEM

Classification name
Absorbable Lung Biopsy Plug
Device class
Class 2
Regulation
21 CFR 878.4755
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

“A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.”

— U.S. Food and Drug Administration, device classification record for product code OMT under 21 CFR 878.4755, via openFDA

Market context for product code OMT

FDA has cleared 2 devices under product code OMT between 2012 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OMT

Recent clearances under product code OMT

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