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Stents, Drains And Dilators For The Biliary Ducts

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5010
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 876.5010 Biliary catheter and accessories

§ 876.5010 Biliary catheter and accessories.

(a) Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

(b) Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]

Stents, Drains And Dilators For The Biliary Ducts

Page Type
Product Code
Regulation Medical Specialty
Gastroenterology and Urology
Review Panel
Gastroenterology and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
876.5010
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 876.5010 Biliary catheter and accessories

§ 876.5010 Biliary catheter and accessories.

(a) Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

(b) Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

[48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71814, Dec. 30, 2019]