Cleared Special

K091681 - FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
(FDA 510(k) Clearance)

K091681 · Entellus Medical, Inc. · Ear, Nose, Throat device

Jul 2009

Decision

28d

Days

Class 1

Risk

K091681 is an FDA 510(k) clearance for the FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT). 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 July 8, 2009, 28 days after receiving the submission on June 10, 2009.

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

Submission Details

510(k) Number	K091681 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 10, 2009
Decision Date	July 08, 2009
Days to Decision	28 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF