FDA Product Code
FDA Product Code FCS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4020
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] | Stryker Endoscopy | 2015-08-20 | Traditional | PDF ↗ |
| K061548 | STRYKER URETERAL ILLUMINATION SYSTEM IV | Stryker Corp. | 2006-09-28 | Traditional | PDF ↗ |
| K982542 | STRYKER URETERAL ILLUMINATOR SYSTEM III | Stryker Endoscopy | 1998-09-22 | Traditional | PDF ↗ |
| K943801 | URIGLOW TRANSILLUMINATING URETERIC STENT MODEL | Rocket of London, Ltd. | 1995-08-15 | Traditional | PDF ↗ |
| K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II | Gabriel Medical, Inc. | 1995-02-07 | Traditional | PDF ↗ |
| K941506 | URETERAL ILLUMINATOR | Apple Medical Corp. | 1994-10-05 | Traditional | PDF ↗ |
| K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM | Gabriel Medical, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K923436 | ILLUMINATED URETERAL CATHETER | Cook Urological, Inc. | 1993-03-05 | Traditional | PDF ↗ |
| K874680 | LASEGUIDE 600A, 600B, 400A, AND 400B | Laser Peripherals, LLC | 1988-03-23 | Traditional | PDF ↗ |
| K880071 | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE | Laserguide | 1988-03-22 | Traditional | PDF ↗ |
Product code FCS · Class II · Gastroenterology, Urology. Data: openFDA.