Product code FCS— Gastroenterology, Urology
GABRIEL URETERAL ILLUMINATOR SYSTEM
- Classification name
- Light, Catheter, Fiberoptic, Glass, Ureteral
- Device class
- Class 2
- Regulation
- 21 CFR 876.4020
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code FCS
FDA has cleared devices under product code FCS between 1988 and 2015, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2015
- 2006
- 1998
- 1995
- 1994
- 1993
- 1988
Top applicants under product code FCS
Recent clearances under product code FCS
- K151243 — STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
- K061548 — STRYKER URETERAL ILLUMINATION SYSTEM IV
- K982542 — STRYKER URETERAL ILLUMINATOR SYSTEM III
- K943801 — URIGLOW TRANSILLUMINATING URETERIC STENT MODEL
- K945088 — GABRIEL URETERAL ILLUMINATOR SYSTEM II
- K941506 — URETERAL ILLUMINATOR
- K940019 — GABRIEL URETERAL ILLUMINATOR SYSTEM
- K923436 — ILLUMINATED URETERAL CATHETER
- K874680 — LASEGUIDE 600A, 600B, 400A, AND 400B
- K880071 — SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE
Data sourced from openFDA. This site is unofficial and independent of the FDA.