FDA 510(k) Application Details - K243722

Device Classification Name	More FDA Info for this Device
510(K) Number	K243722
Device Name	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)
Applicant	Selio Medical Limited Unit 53 Guinness Enterprise Centre, Taylors Lane, Dublin 8 Dublin D08 R9YW IE Other 510(k) Applications for this Company
Contact	Colm McGarvey Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2024
Decision Date	04/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review