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Balloon, Nasal Airway

Page Type
Product Code
Definition
The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.
Physical State
A nasal airway balloon device consists of a catheter with an inflatable, plastic balloon, which is located at the distal, flexible tip. The catheter shaft contains a dual lumen to enable inflation of the balloon and to permit the optional use of a stylet to facilitate advancement of the balloon to the target location.
Technical Method
The nasal airway balloon is inserted into the intranasal space. The balloon is inflated up to the rated pressure and diameter and for the specified duration, to uniformly displace structures in the nasal passage in the region of the inferior turbinate and lower nasal septum. The balloon is then deflated and removed from the nose.
Target Area
Intranasal space in the region of inferior turbinate and lower nasal septum.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
874.4420
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.4420 Ear, nose, and throat manual surgical instrument

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a) Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

(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 § 874.9.

[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, 2000; 72 FR 17400, Apr. 9, 2007]

Balloon, Nasal Airway

Page Type
Product Code
Definition
The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.
Physical State
A nasal airway balloon device consists of a catheter with an inflatable, plastic balloon, which is located at the distal, flexible tip. The catheter shaft contains a dual lumen to enable inflation of the balloon and to permit the optional use of a stylet to facilitate advancement of the balloon to the target location.
Technical Method
The nasal airway balloon is inserted into the intranasal space. The balloon is inflated up to the rated pressure and diameter and for the specified duration, to uniformly displace structures in the nasal passage in the region of the inferior turbinate and lower nasal septum. The balloon is then deflated and removed from the nose.
Target Area
Intranasal space in the region of inferior turbinate and lower nasal septum.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
874.4420
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.4420 Ear, nose, and throat manual surgical instrument

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a) Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

(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 § 874.9.

[51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, 2000; 72 FR 17400, Apr. 9, 2007]