QCX · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5095
Classification
FDA Product Code
QCX
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 868.5095
Review panel
AN
Medical specialty
Anesthesiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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).