| Device |
air-handling apparatus accessory |
| Regulation Description |
Air-handling apparatus accessory. |
| Definition |
An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches. |
| Physical State |
The accessory are made from metal or hard plastic that are either located within the parent device or on the peripheral of the parent device. |
| Technical Method |
The accessory devices provide an interface between the components of the parent device. These devices are much less complex in nature than the parent device or other components which provide the surgical exhaust mechanism or conduit. |
| Target Area |
NA |
| Regulation Medical Specialty |
General & Plastic Surgery |
| Review Panel |
General Hospital |
|---|
| Product Code | QGI |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices
(DHT4B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
878.5080
|
|---|
| 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 |
