Cleared Traditional

Cuffix

K192611 · Biovo Technologies , Ltd. · Anesthesiology
Aug 2020
Decision
328d
Days
Class 2
Risk

About This 510(k) Submission

K192611 is an FDA 510(k) clearance for the Cuffix, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Biovo Technologies , Ltd. (Rosh Haayin, IL). The FDA issued a Cleared decision on August 13, 2020, 328 days after receiving the submission on September 20, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K192611 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2019
Decision Date August 13, 2020
Days to Decision 328 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