FCS · Light, Catheter, Fiberoptic, Glass, Ureteral
Gastroenterology, Urology · 21 CFR 876.4020 · Class 2
Overview
| Product Code | FCS |
|---|---|
| Device Name | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Regulation | 21 CFR 876.4020 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
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.
Cleared Devices (10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] | Stryker Endoscopy | Aug 20, 2015 | SESE |
| K061548 | STRYKER URETERAL ILLUMINATION SYSTEM IV | Stryker Corp. | Sep 28, 2006 | SESE |
| K982542 | STRYKER URETERAL ILLUMINATOR SYSTEM III | Stryker Endoscopy | Sep 22, 1998 | SESE |
| K943801 | URIGLOW TRANSILLUMINATING URETERIC STENT MODEL | Rocket of London, Ltd. | Aug 15, 1995 | SESE |
| K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II | Gabriel Medical, Inc. | Feb 7, 1995 | SESE |
| K941506 | URETERAL ILLUMINATOR | Apple Medical Corp. | Oct 5, 1994 | SESE |
| K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM | Gabriel Medical, Inc. | May 2, 1994 | SESE |
| K923436 | ILLUMINATED URETERAL CATHETER | Cook Urological, Inc. | Mar 5, 1993 | SESE |
| K874680 | LASEGUIDE 600A, 600B, 400A, AND 400B | Laser Peripherals, LLC | Mar 23, 1988 | SESE |
| K880071 | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE | Laserguide | Mar 22, 1988 | SESE |
Top Applicants
- Stryker Endoscopy — 2 clearances
- Gabriel Medical, Inc. — 2 clearances
- Stryker Corp. — 1 clearance
- Rocket of London, Ltd. — 1 clearance
- Laserguide — 1 clearance
