OMTClass IIImplant

Absorbable Lung Biopsy Plug

General, Plastic Surgery · 21 CFR 878.4755

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.

MDR events46All time

Recalls1All time

Registered firms10Currently listed

510(k) clearances2All time

Recent MDR events

46 adverse event reports on file

Event type breakdown

Malfunction43

Injury3

Most-reported manufacturers

Merit Medical Systems, Inc.18 Merit Medical Systems Inc15 Merit Medical Systems Inc. Mex3 Merit Medical Systems Inc - Mexico2 Merit Medical Systems Inc.2 Surgical Specialties México, S. De R.l. De C.v.2 Merit Medical Systems Inc.1 Merit Medical Systems Mexico1

Recalls

1 recall events for this product code

Surgical Specialties Mexico S DE RL DE CV
TerminatedUnknown
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection
Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.
Z-0068-2017 · View FDA record ↗

Registered firms

10 firms currently registered for this product code

510(k) clearances

2 clearances for this product code