Cleared Traditional

ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R

K200968 · Insung Medical Co., Ltd. · Anesthesiology

Dec 2020

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K200968 is an FDA 510(k) clearance for the ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R, a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II — Special Controls, product code CBI), submitted by Insung Medical Co., Ltd. (Gangwon-Do, KR). The FDA issued a Cleared decision on December 28, 2020, 262 days after receiving the submission on April 10, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5740.

Submission Details

510(k) Number	K200968 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2020
Decision Date	December 28, 2020
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5740