Cleared Traditional

FINESS ENDOSCOPE STERILIZATION TRAY

K103213 · Entellus Medical, Inc. · General Hospital

Feb 2011

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K103213 is an FDA 510(k) clearance for the FINESS ENDOSCOPE STERILIZATION TRAY, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Entellus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on February 2, 2011, 93 days after receiving the submission on November 1, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K103213 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2010
Decision Date	February 02, 2011
Days to Decision	93 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850