PosiSep X BAM Hemostat Dressing/Intranasal Splint
K-Number: K220326 · 2022-11-14
ApplicantHemostasis, LLC
Decision Date2022-11-14
Product CodeEMX
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
PosiSep X BAM Hemostat Dressing/Intranasal Splint is a medical device manufactured by Hemostasis, LLC. It received FDA 510(k) clearance on 2022-11-14 under approval 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. It is manufactured by Hemostasis, LLC. The 510(k) number is K220326.
When was PosiSep X BAM Hemostat Dressing/Intranasal Splint approved by the FDA?
PosiSep X BAM Hemostat Dressing/Intranasal Splint received FDA 510(k) clearance on 2022-11-14, under approval number K220326.
What company makes PosiSep X BAM Hemostat Dressing/Intranasal Splint?
PosiSep X BAM Hemostat Dressing/Intranasal Splint is manufactured by Hemostasis, LLC.
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 Devices by Hemostasis, 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.