Cleared Special

K093258 - BLOM-SINGER INDWELLING TEP OCCLUDER
(FDA 510(k) Clearance)

K093258 · Helix Medical, LLC · Ear, Nose, Throat

Mar 2010

Decision

135d

Days

Class 2

Risk

K093258 is an FDA 510(k) clearance for the BLOM-SINGER INDWELLING TEP OCCLUDER, a Prosthesis, Laryngeal (taub) (Class II — Special Controls, product code EWL), submitted by Helix Medical, LLC (Carpinteria, US). The FDA issued a Cleared decision on March 3, 2010, 135 days after receiving the submission on October 19, 2009. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3730.

Submission Details

510(k) Number	K093258 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 2009
Decision Date	March 03, 2010
Days to Decision	135 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF