Cleared Traditional

POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT

K122494 · Hemostasis, LLC · Ear, Nose, Throat

Mar 2013

Decision

223d

Days

Class 1

Risk

About This 510(k) Submission

K122494 is an FDA 510(k) clearance for the POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT, a Splint, Intranasal Septal (Class I — General Controls, product code LYA), submitted by Hemostasis, LLC (St. Paul, US). The FDA issued a Cleared decision on March 27, 2013, 223 days after receiving the submission on August 16, 2012. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4780.

Submission Details

510(k) Number	K122494 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2012
Decision Date	March 27, 2013
Days to Decision	223 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF