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510(k) K243722

Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) by Selio Medical Limited — Product Code OMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2025
Date Received
December 3, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorbable Lung Biopsy Plug
Device Class
Class II
Regulation Number
878.4755
Review Panel
AN
Submission Type

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.

Other clearances for product code OMT

  • DEN090007 — BIO-SEAL LUNG BIOPSY TRACT SYSTEM (December 19, 2012)