PosiSep X BAM Hemostat Dressing/Intranasal Splint— 510(k) K220326

Name: FDA 510(k) clearance K220326
Creator: U.S. Food and Drug Administration
Published: 2022-11-14

Substantially Equivalent

Hemostasis, LLC

FDA 510(k) clearance K220326 for PosiSep X BAM Hemostat Dressing/Intranasal Splint, Substantially Equivalent on 2022-11-14. Applicant: Hemostasis, LLC. Device class: 1.

Clearance details

Applicant: Hemostasis, LLC
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 2022-02-04
Decision date: 2022-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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K041446 — NASALCEASE2004-07-01
K000108 — RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 1002000-05-23
K993362 — HYLASINE2000-03-13
K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING1999-09-14
K982731 — MEROGEL NASAL DRESSING AND SINUS STENT1999-02-02

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K122494 — POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT2013-03-27
K122886 — NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING2012-11-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.