Stryker Ureteral Illuminator System III
FDA 510(k) K982542 · Stryker Endoscopy
510(k) numberK982542
Submission
- Device name
- Stryker Ureteral Illuminator System III
- Applicant
- Stryker Endoscopy
Santa Clara, CA, US - Received
- July 21, 1998
- Decision date
- September 22, 1998
- 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 |
| K061548 | Stryker Ureteral Illumination System IVFCS · Traditional | Stryker Corp. | 09/28/2006SE |
| 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 |
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Questions and answers
When was Stryker Ureteral Illuminator System III cleared by the FDA?
Stryker Ureteral Illuminator System III (K982542) received a 510(k) decision of Substantially Equivalent on September 22, 1998, 63 days after the submission was received.
What is the product code of K982542?
The FDA product code is FCS – Light, Catheter, Fiberoptic, Glass, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4020.