510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN170055Unknown

Retrograde Intubation Set

Cook Incorporated, Bloomington ID / Direct, Unknown
FDA source (opens on fda.gov)

DEN170055 is the FDA 510(k) clearance record for Retrograde Intubation Set, a class II device, cleared for Cook Incorporated on under FDA product code QCX. FDA's definition for product code QCX reads: "A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (21...". FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming DEN170055.

Clearance record

Decision date
Received
(443 days to decision)
Product code
QCX Retrograde Intubation Set
Regulation
21 CFR 868.5095
Device class
Class II
Review panel
Anesthesiology
Applicant
Cook Incorporated 750 Daniels Way, Bloomington ID
Third party review
No

Clearances, product code QCX

Trailing 12 months

FDA records hold no clearances under product code QCX in the trailing twelve months.

FDA records show no clearances under product code QCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260