STRYKER URETERAL ILLUMINATION SYSTEM IV
FDA 510(k) clearance K061548 · decided 2006-09-28
Clearance details
- K-number
- K061548
- Device name
- STRYKER URETERAL ILLUMINATION SYSTEM IV
- Applicant
- Stryker Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-05
- Decision date
- 2006-09-28
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- FCS
- Device class
- 2
- Regulation number
- 876.4020
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITAGEL RT3 SUTGICAL HEMOSTAT (P050044/S033) | Stryker Corp. | 2017-03-02 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S032) | Stryker Corp. | 2015-07-16 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S031) | Stryker Corp. | 2015-04-14 |
| VITAGEL SURGICAL HEMOSTAT (RT3) (P050044/S030) | Stryker Corp. | 2015-04-13 |
| VITAGEL RT3 SURGICAL HEMOSTAT (P050044/S029) | Stryker Corp. | 2014-12-12 |
| VITAGEL RT3 DELIVERY SYSTEM (P050044/S028) | Stryker Corp. | 2014-06-05 |
| VITAGEL SURGICAL HEMOSTAT (VITAGEL) (P050044/S026) | Stryker Corp. | 2014-02-11 |
| RT3 SURGICAL HEMOSTAT (P050044/S027) | Stryker Corp. | 2014-01-27 |