Last synced on 24 June 2022 at 11:05 pm

Oral Airway Assist

Page Type
Product Code
Definition
To assist in maintaining an open airway.
Physical State
Consists of Fortiflex B53-35H--1 1, High Density Polyethylene and is to be used with a latex strap.
Technical Method
To be placed in the mouth and increase the pharyngeal airspace.
Target Area
The oropharyngeal space.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
868.5110
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5110 Oropharyngeal airway

§ 868.5110 Oropharyngeal airway.

(a) Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]

Oral Airway Assist

Page Type
Product Code
Definition
To assist in maintaining an open airway.
Physical State
Consists of Fortiflex B53-35H--1 1, High Density Polyethylene and is to be used with a latex strap.
Technical Method
To be placed in the mouth and increase the pharyngeal airspace.
Target Area
The oropharyngeal space.
Regulation Medical Specialty
Anesthesiology
Review Panel
Anesthesiology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
868.5110
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 868.5110 Oropharyngeal airway

§ 868.5110 Oropharyngeal airway.

(a) Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001]