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FDA 510(k)

PosiSep EAR Fragmentable Ear Dressing

K-Number: K210411 · 2022-05-05

ApplicantHemostasis, LLC
Decision Date2022-05-05
Product CodeNHB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PosiSep EAR Fragmentable Ear Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Hemostasis, LLC. It received FDA 510(k) clearance on 2022-05-05 under 510(k) 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. The listed applicant is Hemostasis, LLC. The 510(k) number is K210411.

When did PosiSep EAR Fragmentable Ear Dressing receive FDA 510(k) clearance?

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

Who is the listed applicant for PosiSep EAR Fragmentable Ear Dressing?

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 EAR Fragmentable Ear Dressing?

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

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 Splint

Related Devices (Code: NHB)

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.

K260620SeptAlign (SPLN001)Spirair, Inc.K251790SeptAlignSpirair, Inc.K233569SeptAlignSpirair, Inc.K223167Spirair Nasal Septal StrapSpirair, Inc.K192661LATERA Absorbable Nasal Implant SystemEntellus Medical, Inc. (Aka Stryker Ent)K183015PuraSinus3-D Matrix, Inc.

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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