Cleared Traditional

AG GUFFILL

K122721 · Hospitech Respiration , Ltd. · Anesthesiology
May 2013
Decision
240d
Days
Class 2
Risk

About This 510(k) Submission

K122721 is an FDA 510(k) clearance for the AG GUFFILL, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Hospitech Respiration , Ltd. (Binyamina, IL). The FDA issued a Cleared decision on May 3, 2013, 240 days after receiving the submission on September 5, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K122721 FDA.gov
FDA Decision Cleared SESE
Date Received September 05, 2012
Decision Date May 03, 2013
Days to Decision 240 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750