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FDA 510(k)

POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT

K-Number: K122494 · 2013-03-27

ApplicantHemostasis, LLC
Decision Date2013-03-27
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Hemostasis, LLC. It received FDA 510(k) clearance on 2013-03-27 under 510(k) number K122494. 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 POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT?

POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT is a medical device that received FDA 510(k) clearance on 2013-03-27. The listed applicant is Hemostasis, LLC. The 510(k) number is K122494.

When did POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT receive FDA 510(k) clearance?

POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT received FDA 510(k) clearance on 2013-03-27, under 510(k) number K122494.

Who is the listed applicant for POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT?

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

What is the FDA product code for POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT?

The FDA product code for POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT is LYA.

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Other records listing Hemostasis, LLC as applicant

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.

K234131Resolv Endoscopic Hemostat SystemK220326PosiSep X BAM Hemostat Dressing/Intranasal SplintK210411PosiSep EAR Fragmentable Ear DressingK122886NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSINGK120958POSISEP AND POSISEP X HEMOSTAT DRESSINGSK102459NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE

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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

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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