Gabriel Ureteral Illuminator System
FDA 510(k) K940019 · Gabriel Medical, Inc.
510(k) numberK940019
Submission
- Device name
- Gabriel Ureteral Illuminator System
- Applicant
- Gabriel Medical, Inc.
North Attleboro, MA, US - Received
- January 3, 1994
- Decision date
- May 2, 1994
- 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 |
| 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 |
| 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 |
|---|---|---|
| K960173 | Infra Vision Bougie Kit, Infra Vision Esophageal KitFAT · Traditional | 06/27/1996SE |
| K945088 | Gabriel Ureteral Illuminator System IIFCS · Traditional | 02/07/1995SE |
| K945297 | Infra Vision Imaging SystemGCJ · Traditional | 12/20/1994SE |
| K901385 | Gabriel Medical CLS Thermal RecorderDSF · Traditional | 05/09/1990SE |
Questions and answers
When was Gabriel Ureteral Illuminator System cleared by the FDA?
Gabriel Ureteral Illuminator System (K940019) received a 510(k) decision of Substantially Equivalent on May 2, 1994, 119 days after the submission was received.
What is the product code of K940019?
The FDA product code is FCS – Light, Catheter, Fiberoptic, Glass, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4020.