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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 the device name listed in this FDA 510(k) record. The listed applicant is Biomed Ent, Inc.. It received FDA 510(k) clearance on 2023-03-22 under 510(k) 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. The listed applicant is Biomed Ent, Inc.. The 510(k) number is K230142.

When did Epi-Stop Nasal Gel/epistaxis pack receive FDA 510(k) clearance?

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

Who is the listed applicant for Epi-Stop Nasal Gel/epistaxis pack?

The FDA 510(k) record lists Biomed Ent, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: LYA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243655TurbAlignSpirair, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLCK202623Novapak Nasal Sinus Packing and StentMedtronic XomedK181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLCK170913Composite Removable Sinus Stent SystemSts Medical

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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