Cleared Traditional

K110739 - ENTELLUS MEDICAL SINUS GUIDEWIRE
(FDA 510(k) Clearance)

K110739 · Entellus Medical, Inc. · Ear, Nose, Throat device

Jun 2011

Decision

89d

Days

Class 1

Risk

K110739 is an FDA 510(k) clearance for the ENTELLUS MEDICAL SINUS GUIDEWIRE. This device is classified as a Instrument, Ent Manual Surgical (Class I - General Controls, product code LRC).

Submitted by Entellus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 14, 2011, 89 days after receiving the submission on March 17, 2011.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K110739 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 17, 2011
Decision Date	June 14, 2011
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF