510(k) K151243
- Device
- STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source And IRIS Ureteral Kit]
- Applicant
- Stryker Endoscopy
- 510(k) number
- K151243
- Product code
- FCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-08-20
- Date received
- 2015-05-11
- Regulation
- 876.4020
- Classification name
- Light, Catheter, Fiberoptic, Glass, Ureteral
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GOLNAZ MOEINI
- Address
- 5900 Optical Ct. San Jose CA US 95138 95138
FDA Registration Numbers#
- 3002807314
- 3015532525
- 3010155661
- 3010707607
- 3008837339
- 1820334
- 3008328690
- 9610617
- 3014342096
- 3008132398
- 2936485
- 3010202439
- 3007303113
Source Documents#
Other 510(k) Records For Product Code FCS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061548 | STRYKER URETERAL ILLUMINATION SYSTEM IV | Stryker Corp. | 2006-09-28 |
| K982542 | STRYKER URETERAL ILLUMINATOR SYSTEM III | Stryker Endoscopy | 1998-09-22 |
| K943801 | URIGLOW TRANSILLUMINATING URETERIC STENT MODEL | Rocket of London, Ltd. | 1995-08-15 |
| K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II | Gabriel Medical, Inc. | 1995-02-07 |
| K941506 | URETERAL ILLUMINATOR | Apple Medical Corp. | 1994-10-05 |
| K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM | Gabriel Medical, Inc. | 1994-05-02 |
| K923436 | ILLUMINATED URETERAL CATHETER | Cook Urological, Inc. | 1993-03-05 |
| K874680 | LASEGUIDE 600A, 600B, 400A, AND 400B | Laser Peripherals, LLC | 1988-03-23 |
| K880071 | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE | Laserguide | 1988-03-22 |
Legacy Summary#
summary
FDA Review#
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