FCS — Light, Catheter, Fiberoptic, Glass, Ureteral Class II
FDA product code FCS covers "Light, Catheter, Fiberoptic, Glass, Ureteral", a Class II medical device regulated under 21 CFR 876.4020. Submissions are reviewed by the Gastroenterology, Urology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCS
- Device Class
- Class II
- Regulation Number
- 876.4020
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K151243 | stryker endoscopy | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral | August 20, 2015 |
| K061548 | stryker | STRYKER URETERAL ILLUMINATION SYSTEM IV | September 28, 2006 |
| K982542 | stryker endoscopy | STRYKER URETERAL ILLUMINATOR SYSTEM III | September 22, 1998 |
| K943801 | rocket of london | URIGLOW TRANSILLUMINATING URETERIC STENT MODEL | August 15, 1995 |
| K945088 | gabriel medical | GABRIEL URETERAL ILLUMINATOR SYSTEM II | February 7, 1995 |
| K941506 | apple medical | URETERAL ILLUMINATOR | October 5, 1994 |
| K940019 | gabriel medical | GABRIEL URETERAL ILLUMINATOR SYSTEM | May 2, 1994 |
| K923436 | cook urological | ILLUMINATED URETERAL CATHETER | March 5, 1993 |
| K874680 | laser peripherals | LASEGUIDE 600A, 600B, 400A, AND 400B | March 23, 1988 |
| K880071 | laserguide | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE | March 22, 1988 |