Ureteral Illuminator
FDA 510(k) K941506 · Apple Medical Corp.
510(k) numberK941506
Submission
- Device name
- Ureteral Illuminator
- Applicant
- Apple Medical Corp.
Bolton, MA, US - Received
- March 29, 1994
- Decision date
- October 5, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K061651 | Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158HGI · Traditional | 10/20/2006SE |
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | 04/26/2005SE |
| K041131 | Apple Medical Ob Mobius Elastic RetractorGCJ · Traditional | 05/13/2004SE |
| K014005 | Apple Medical Mobius Elastic RetractorGCJ · Traditional | 02/15/2002SE |
| K000026 | Apple Medical One-Touch Uterine SamplerHHK · Traditional | 03/31/2000SE |
| K970788 | Pneumo-Matic Insufflation NeedleFHO · Traditional | 03/27/1997SE |
| K961460 | Lweet Cone Biopsy InstrumentHGI · Traditional | 11/19/1996SE |
| K952841 | The AssistantFHA · Traditional | 08/18/1995SE |
Questions and answers
When was Ureteral Illuminator cleared by the FDA?
Ureteral Illuminator (K941506) received a 510(k) decision of Substantially Equivalent on October 5, 1994, 190 days after the submission was received.
What is the product code of K941506?
The FDA product code is FCS – Light, Catheter, Fiberoptic, Glass, Ureteral, a Class II (moderate risk) device regulated under 21 CFR 876.4020.