STRYKER URETERAL ILLUMINATOR SYSTEM III
FDA 510(k) clearance K982542 · decided 1998-09-22
Clearance details
- K-number
- K982542
- Device name
- STRYKER URETERAL ILLUMINATOR SYSTEM III
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1998-07-21
- Decision date
- 1998-09-22
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FCS
- Device class
- 2
- Regulation number
- 876.4020
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumi recall (Z-1866-2008) | Stryker Endoscopy | 2008-09-16 |