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FDA 510(k)

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)

K-Number: K243722 · 2025-04-08

ApplicantSelio Medical Limited
Decision Date2025-04-08
Product CodeOMT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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) is the device name listed in this FDA 510(k) record. The listed applicant is Selio Medical Limited. It received FDA 510(k) clearance on 2025-04-08 under 510(k) number K243722. The device is classified under product code OMT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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)?

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) is a medical device that received FDA 510(k) clearance on 2025-04-08. The listed applicant is Selio Medical Limited. The 510(k) number is K243722.

When did 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) receive FDA 510(k) clearance?

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) received FDA 510(k) clearance on 2025-04-08, under 510(k) number K243722.

Who is the listed applicant 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)?

The FDA 510(k) record lists Selio Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code 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)?

The FDA product code 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) is OMT.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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