| Device |
balloon, nasal airway |
| Regulation Description |
Ear, nose, and throat manual surgical instrument. |
| 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 |
|---|
| Product Code | QGK |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
874.4420
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
