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FDA 510(k)

Epi-Stop Nasal Gel/epistaxis pack

K-Number: K230142 · 2023-03-22

ApplicantBiomed Ent, Inc.
Decision Date2023-03-22
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Epi-Stop Nasal Gel/epistaxis pack is a medical device manufactured by Biomed Ent, Inc.. It received FDA 510(k) clearance on 2023-03-22 under approval number K230142. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Epi-Stop Nasal Gel/epistaxis pack?

Epi-Stop Nasal Gel/epistaxis pack is a medical device that received FDA 510(k) clearance on 2023-03-22. It is manufactured by Biomed Ent, Inc.. The 510(k) number is K230142.

When was Epi-Stop Nasal Gel/epistaxis pack approved by the FDA?

Epi-Stop Nasal Gel/epistaxis pack received FDA 510(k) clearance on 2023-03-22, under approval number K230142.

What company makes Epi-Stop Nasal Gel/epistaxis pack?

Epi-Stop Nasal Gel/epistaxis pack is manufactured by Biomed Ent, Inc..

What is the FDA product code for Epi-Stop Nasal Gel/epistaxis pack?

The FDA product code for Epi-Stop Nasal Gel/epistaxis pack is LYA.

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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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