FDA 510(k)

PosiSep X BAM Hemostat Dressing/Intranasal Splint

K-Number: K220326 · 2022-11-14

Decision Date2022-11-14

Product CodeEMX

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

PosiSep X BAM 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 2022-11-14 under 510(k) number K220326. The device is classified under product code EMX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PosiSep X BAM Hemostat Dressing/Intranasal Splint?

PosiSep X BAM Hemostat Dressing/Intranasal Splint is a medical device that received FDA 510(k) clearance on 2022-11-14. The listed applicant is Hemostasis, LLC. The 510(k) number is K220326.

When did PosiSep X BAM Hemostat Dressing/Intranasal Splint receive FDA 510(k) clearance?

PosiSep X BAM Hemostat Dressing/Intranasal Splint received FDA 510(k) clearance on 2022-11-14, under 510(k) number K220326.

Who is the listed applicant for PosiSep X BAM 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 X BAM Hemostat Dressing/Intranasal Splint?

The FDA product code for PosiSep X BAM Hemostat Dressing/Intranasal Splint is EMX.

Other records listing Hemostasis, LLC as applicant

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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.