FCS
10 FDA 510(k) clearances · Product code
119 daysmedian time to decision
377 days90th percentile
10clearances measured
FDA profile
- Official device name
- Light, Catheter, Fiberoptic, Glass, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4020
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 1996: 1 · 2017: 17 · 2022: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] (K151243) | Stryker Endoscopy | 2015-08-20 |
| STRYKER URETERAL ILLUMINATION SYSTEM IV (K061548) | Stryker Corp. | 2006-09-28 |
| STRYKER URETERAL ILLUMINATOR SYSTEM III (K982542) | Stryker Endoscopy | 1998-09-22 |
| URIGLOW TRANSILLUMINATING URETERIC STENT MODEL (K943801) | Rocket of London, Ltd. | 1995-08-15 |
| GABRIEL URETERAL ILLUMINATOR SYSTEM II (K945088) | Gabriel Medical, Inc. | 1995-02-07 |
| URETERAL ILLUMINATOR (K941506) | Apple Medical Corp. | 1994-10-05 |
| GABRIEL URETERAL ILLUMINATOR SYSTEM (K940019) | Gabriel Medical, Inc. | 1994-05-02 |
| ILLUMINATED URETERAL CATHETER (K923436) | Cook Urological, Inc. | 1993-03-05 |
| LASEGUIDE 600A, 600B, 400A, AND 400B (K874680) | Laser Peripherals, LLC | 1988-03-23 |
| SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE (K880071) | Laserguide | 1988-03-22 |
Track FCS automatically
Every clearance here is in the API, with alerts when new ones post.