21 CFR 876.5010 — Bag, Bile Collecting
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5010
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EXF | Bag, Bile Collecting | 2 | 9 | |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 474 | Implant, Life-Sustaining |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 2 | 25 | 3rd Party |
| LQR | Dislodger, Stone, Biliary | 2 | 38 | 3rd Party |
| NML | Catheter, Biliary, Reprocessed | 2 | 1 | 3rd Party |
| PTT | Biliary Catheter For Irrigation And Contrast Injection, Exempt | 2 | 0 |
Special Controls
EXF — Bag, Bile Collecting
*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.
eCFR
FGE — Stents, Drains And Dilators For The Biliary Ducts
*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.
eCFR
GCA — Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
*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.
eCFR
LQR — Dislodger, Stone, Biliary
*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.
eCFR
NML — Catheter, Biliary, Reprocessed
*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.
eCFR
PTT — Biliary Catheter For Irrigation And Contrast Injection, Exempt
*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.
eCFR
