21 CFR 876.4020 — Light, Catheter, Fiberoptic, Glass, Ureteral
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4020
Identification
A fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits light throughout its length and is shaped so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.
Classification Rationale
Class II (special controls). The device 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 |
|---|---|---|---|---|
| FCS | Light, Catheter, Fiberoptic, Glass, Ureteral | 2 | 10 |
Special Controls
FCS — Light, Catheter, Fiberoptic, Glass, Ureteral
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
eCFR
