510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233341Substantially Equivalent

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K233341 is the FDA 510(k) clearance record for Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410), a class II device, cleared for Covidien, LLC on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K233341.

Clearance record

Decision date
Received
(234 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Covidien, LLC 6135 Gunbarrel Ave., Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTR

Trailing 12 months
2 clearances under product code BTR in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260