Cleared Traditional

PosiSep X BAM Hemostat Dressing/Intranasal Splint

K220326 · Hemostasis, LLC · Ear, Nose, Throat
Nov 2022
Decision
283d
Days
Class 1
Risk

About This 510(k) Submission

K220326 is an FDA 510(k) clearance for the PosiSep X BAM Hemostat Dressing/Intranasal Splint, a Balloon, Epistaxis (Class I — General Controls, product code EMX), submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on November 14, 2022, 283 days after receiving the submission on February 4, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4100.

Submission Details

510(k) Number K220326 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2022
Decision Date November 14, 2022
Days to Decision 283 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EMX — Balloon, Epistaxis
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4100

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