Light, Catheter, Fiberoptic, Glass, Ureteral
The Ureteral Fiberoptic Glass Catheter Light (product code FCS) is a device that uses fiberoptic glass elements to transmit light through a catheter to illuminate the ureteral lumen during urological procedures. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 876.4020 in the Gastroenterology and Urology specialty. No special flags apply.
Basic Information
- Product Code
- FCS
- Device Class
- FDA class 2
- Regulation Number
- 876.4020
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] | Aug 20, 2015 | Substantially Equivalent | Stryker Endoscopy |
| K061548 | STRYKER URETERAL ILLUMINATION SYSTEM IV | Sep 28, 2006 | Substantially Equivalent | Stryker Corp. |
| K982542 | STRYKER URETERAL ILLUMINATOR SYSTEM III | Sep 22, 1998 | Substantially Equivalent | Stryker Endoscopy |
| K943801 | URIGLOW TRANSILLUMINATING URETERIC STENT MODEL | Aug 15, 1995 | Substantially Equivalent | Rocket of London, Ltd. |
| K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II | Feb 07, 1995 | Substantially Equivalent | Gabriel Medical, Inc. |
| K941506 | URETERAL ILLUMINATOR | Oct 05, 1994 | Substantially Equivalent | Apple Medical Corp. |
| K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM | May 02, 1994 | Substantially Equivalent | Gabriel Medical, Inc. |
| K923436 | ILLUMINATED URETERAL CATHETER | Mar 05, 1993 | Substantially Equivalent | Cook Urological, Inc. |
| K874680 | LASEGUIDE 600A, 600B, 400A, AND 400B | Mar 23, 1988 | Substantially Equivalent | Laser Peripherals, LLC |
| K880071 | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE | Mar 22, 1988 | Substantially Equivalent | Laserguide |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.