DeviceClearance

Product code QCX— Anesthesiology

Retrograde Intubation Set

Device class
Class 2
Regulation
21 CFR 868.5095
Advisory panel
Anesthesiology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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 CFR 8685090), syringe (21 CFR 880.5860), and hemostats (21 CFR 878.4800).”

— U.S. Food and Drug Administration, device classification record for product code QCX under 21 CFR 868.5095, via openFDA

Market context for product code QCX

FDA has cleared 1 device under product code QCX, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QCX

Recent clearances under product code QCX

Data sourced from openFDA. This site is unofficial and independent of the FDA.