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Catheter, Drainage, Intraoral/Extraoral

Page Type
Product Code
Definition
To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones
Physical State
It is a flexible, single lumen, disposable drainage cannula made of radio-opaque polyurethane material
Technical Method
The drainage cannula is inserted which allows the fluid to drain following endoscopic removal of salivary gland stones
Target Area
Salivary gland
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4200
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4200 Introduction/drainage catheter and accessories

§ 878.4200 Introduction/drainage catheter and accessories.

(a) Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

(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 § 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]

Catheter, Drainage, Intraoral/Extraoral

Page Type
Product Code
Definition
To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones
Physical State
It is a flexible, single lumen, disposable drainage cannula made of radio-opaque polyurethane material
Technical Method
The drainage cannula is inserted which allows the fluid to drain following endoscopic removal of salivary gland stones
Target Area
Salivary gland
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
878.4200
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4200 Introduction/drainage catheter and accessories

§ 878.4200 Introduction/drainage catheter and accessories.

(a) Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

(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 § 878.9.

[53 FR 23872, June 24, 1988, as amended at 65 FR 2318, Jan. 14, 2000]