Cleared Traditional

BLOM-SINGER SEPTAL PERFORATION PROSTHESIS

K131745 · Helix Medical, LLC · Ear, Nose, Throat
Sep 2013
Decision
96d
Days
—
Risk

About This 510(k) Submission

K131745 is an FDA 510(k) clearance for the BLOM-SINGER SEPTAL PERFORATION PROSTHESIS, a Button, Nasal Septal, submitted by Helix Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on September 17, 2013, 96 days after receiving the submission on June 13, 2013. This device falls under the Ear, Nose, Throat review panel.

Submission Details

510(k) Number K131745 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2013
Decision Date September 17, 2013
Days to Decision 96 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LFB — Button, Nasal Septal
Device Class —