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FDA 510(k)

NASAL/EPISTAXIS PACK

K-Number: K113585 · 2012-04-25

ApplicantCogent Therapeutics, LLC
Decision Date2012-04-25
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NASAL/EPISTAXIS PACK is the device name listed in this FDA 510(k) record. The listed applicant is Cogent Therapeutics, LLC. It received FDA 510(k) clearance on 2012-04-25 under 510(k) number K113585. 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 NASAL/EPISTAXIS PACK?

NASAL/EPISTAXIS PACK is a medical device that received FDA 510(k) clearance on 2012-04-25. The listed applicant is Cogent Therapeutics, LLC. The 510(k) number is K113585.

When did NASAL/EPISTAXIS PACK receive FDA 510(k) clearance?

NASAL/EPISTAXIS PACK received FDA 510(k) clearance on 2012-04-25, under 510(k) number K113585.

Who is the listed applicant for NASAL/EPISTAXIS PACK?

The FDA 510(k) record lists Cogent Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NASAL/EPISTAXIS PACK?

The FDA product code for NASAL/EPISTAXIS PACK is LYA.

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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.K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.K213153SPIWay Endonasal Access GuideSpiway, LLCK202623Novapak Nasal Sinus Packing and StentMedtronic XomedK181696ChitoZolveGyrus Acmi, Inc.K180141SPIWay Endonasal Access GuideSpiway, LLC

Official Source

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

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