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Needle, Emergency Airway

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5090
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Third Party Eligible

CFR § 868.5090 Emergency airway needle

§ 868.5090 Emergency airway needle.

(a) Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.

(b) Classification. Class II (performance standards).

Needle, Emergency Airway

Page Type
Product Code
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
868.5090
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
Yes
Third Party Review
Third Party Eligible

CFR § 868.5090 Emergency airway needle

§ 868.5090 Emergency airway needle.

(a) Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.

(b) Classification. Class II (performance standards).