GABRIEL URETERAL ILLUMINATOR SYSTEM II
Device Facts
| Record ID | K945088 |
|---|---|
| Device Name | GABRIEL URETERAL ILLUMINATOR SYSTEM II |
| Applicant | Gabriel Medical, Inc. |
| Product Code | FCS · Gastroenterology, Urology |
| Decision Date | Feb 7, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4020 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
