Cleared Traditional

PosiSep EAR Fragmentable Ear Dressing

K210411 · Hemostasis, LLC · Ear, Nose, Throat
May 2022
Decision
448d
Days
Class 2
Risk

About This 510(k) Submission

K210411 is an FDA 510(k) clearance for the PosiSep EAR Fragmentable Ear Dressing, a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II — Special Controls, product code NHB), submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on May 5, 2022, 448 days after receiving the submission on February 11, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K210411 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2021
Decision Date May 05, 2022
Days to Decision 448 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code NHB — Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3620
Definition Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.