K-number	K243785
Device name	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced
Applicant	Covidien, LLC
Product code	BTR
Device class	Class II
Decision date	Sep 25, 2025
Decision	Substantially Equivalent
Regulation	868.5730

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Shiley Oral/Nasal Tracheal Tubes are intended for oral or nasal intubation to manage airways, including in procedures requiring neck flexing or patient repositioning. The product line includes variants with reinforced tubes, cuffed and cuffless options, and some with specialized features like TaperGuard Cuff or Murphy Eye.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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