FDA 510(k)

PosiSep EAR Fragmentable Ear Dressing

K-Number: K210411 · 2022-05-05

Decision Date2022-05-05

Product CodeNHB

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

PosiSep EAR Fragmentable Ear Dressing is a medical device manufactured by Hemostasis, LLC. It received FDA 510(k) clearance on 2022-05-05 under approval number K210411. The device is classified under product code NHB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PosiSep EAR Fragmentable Ear Dressing?

PosiSep EAR Fragmentable Ear Dressing is a medical device that received FDA 510(k) clearance on 2022-05-05. It is manufactured by Hemostasis, LLC. The 510(k) number is K210411.

When was PosiSep EAR Fragmentable Ear Dressing approved by the FDA?

PosiSep EAR Fragmentable Ear Dressing received FDA 510(k) clearance on 2022-05-05, under approval number K210411.

What company makes PosiSep EAR Fragmentable Ear Dressing?

PosiSep EAR Fragmentable Ear Dressing is manufactured by Hemostasis, LLC.

What is the FDA product code for PosiSep EAR Fragmentable Ear Dressing?

The FDA product code for PosiSep EAR Fragmentable Ear Dressing is NHB.

Other Devices by Hemostasis, LLC

K220326PosiSep X BAM Hemostat Dressing/Intranasal Splint K234131Resolv Endoscopic Hemostat System

Related Devices (Code: NHB)

K161191Latera Absorbable Nasal ImplantSpirox, Inc. K192661LATERA Absorbable Nasal Implant SystemEntellus Medical, Inc. (Aka Stryker Ent) K183015PuraSinus3-D Matrix, Inc. K223167Spirair Nasal Septal StrapSpirair, Inc. K233569SeptAlignSpirair, Inc. K251790SeptAlignSpirair, Inc.

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.