510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243722Substantially Equivalent

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)

Selio Medical Limited, Dublin, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243722 is the FDA 510(k) clearance record for 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), a class II device, cleared for Selio Medical Limited on under FDA product code OMT (Absorbable Lung Biopsy Plug). FDA's definition for product code OMT reads: "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...". FDA records list one 510(k) clearance for Selio Medical Limited. As of , FDA records show no recalls naming K243722.

Clearance record

Decision date
Received
(126 days to decision)
Product code
OMT Absorbable Lung Biopsy Plug
Regulation
21 CFR 878.4755
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Selio Medical Limited Unit 53 Guinness Enterprise Centre,, Dublin, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMT

Trailing 12 months

FDA records hold no clearances under product code OMT in the trailing twelve months.

FDA records show no clearances under product code OMT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260