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U.S. Department of Health and Human Services

Product Classification

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Device absorbable lung biopsy plug
Regulation Description Absorbable lung biopsy plug.
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.
Physical State Polymerized hydrogel plug, cylindrical in shape and placed by a deployment system following lung biopsy by smaller biopsy needle/instrument.
Technical Method Upon deployment into a lung biopsy tract, the plug expands to fill the biopsy void provide closure of the biopsy void.
Target Area to be used in the lung, specifically in punctures left by percutenous, transthoracic needles
Regulation Medical Specialty General & Plastic Surgery
Review Panel Anesthesiology
Product CodeOMT
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Anesthesiology Devices Branch (ANDB)
Submission Type 510(k)
Regulation Number 878.4755
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible