Stryker Ureteral Illumination System IV
FDA 510(k) K061548 · Stryker Corp.
510(k) numberK061548
Submission
- Device name
- Stryker Ureteral Illumination System IV
- Applicant
- Stryker Corp.
San Jose, CA, US - Received
- June 5, 2006
- Decision date
- September 28, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCS – Light, Catheter, Fiberoptic, Glass, Ureteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4020
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]FCS · Traditional | Stryker Endoscopy | 08/20/2015SE |
| K982542 | Stryker Ureteral Illuminator System IIIFCS · Traditional | Stryker Endoscopy | 09/22/1998SE |
| K943801 | Uriglow Transilluminating Ureteric Stent ModelFCS · Traditional | Rocket of London, Ltd. | 08/15/1995SE |
| K945088 | Gabriel Ureteral Illuminator System IIFCS · Traditional | Gabriel Medical, Inc. | 02/07/1995SE |
| K941506 | Ureteral IlluminatorFCS · Traditional | Apple Medical Corp. | 10/05/1994SE |
| K940019 | Gabriel Ureteral Illuminator SystemFCS · Traditional | Gabriel Medical, Inc. | 05/02/1994SE |
| K923436 | Illuminated Ureteral CatheterFCS · Traditional | Cook Urological, Inc. | 03/05/1993SE |
| K874680 | Laseguide 600A, 600B, 400A, and 400BFCS · Traditional | Laser Peripherals, LLC | 03/23/1988SE |
| K880071 | Surgi-Light Nd:Yag Laser for Urological UseFCS · Traditional | Laserguide | 03/22/1988SE |
More from Laserguide
| 510(k) | Device | Decision |
|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | 06/29/2026SE |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB · Traditional | 02/03/2026SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | 12/19/2025SE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB · Traditional | 08/20/2025SE |
| K250163 | T2 Alpha Femur Retrograde Nailing SystemHSB · Traditional | 08/13/2025SE |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional | 10/06/2024SE |
| K233919 | VariAx 2 Distal Radius SystemHRS · Traditional | 03/25/2024SE |
| K233741 | Hoffmann LRF SystemKTT · Special | 12/21/2023SE |
| K230045 | HipCheckQIH · Traditional | 09/29/2023SE |
| K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN · Traditional | 09/20/2023SE |
Questions and answers
When was Stryker Ureteral Illumination System IV cleared by the FDA?
Stryker Ureteral Illumination System IV (K061548) received a 510(k) decision of Substantially Equivalent on September 28, 2006, 115 days after the submission was received.
What is the product code of K061548?
The FDA product code is FCS – Light, Catheter, Fiberoptic, Glass, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4020.