Cleared Traditional

Shiley? Pediatric Oral/Nasal Endotracheal Tube with TaperGuard? Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160)

K223130 · Covidien · Anesthesiology
Aug 2023
Decision
331d
Days
Class 2
Risk

About This 510(k) Submission

K223130 is an FDA 510(k) clearance for the Shiley? Pediatric Oral/Nasal Endotracheal Tube with TaperGuard? Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160), a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on August 30, 2023, 331 days after receiving the submission on October 3, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K223130 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2022
Decision Date August 30, 2023
Days to Decision 331 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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