Fiber Optic Light Guide or Fiber Optic Cable
FDA 510(k) K901035 · Cuda Products Co.
510(k) numberK901035
Submission
- Device name
- Fiber Optic Light Guide or Fiber Optic Cable
- Applicant
- Cuda Products Co.
Jacksonville, FL, US - Received
- March 6, 1990
- Decision date
- April 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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| K122637 | Lite Decompression System- Light Cable Model 48089999FST · Traditional | Stryker Spine | 11/01/2012SE |
| K113697 | Eigr Surgical Illumination SystemFST · Special | Invuity, Inc. | 02/10/2012SE |
| K113330 | CablecapFST · Traditional | Sensormed | 01/12/2012SE |
| K102266 | Isoled Ac-Powered LED Headlight SystemFST · Traditional | Isolux, LLC | 09/24/2010SE |
| K101496 | Cablecap Model: WLF, STZ, AcmFST · Traditional | Sensormed | 09/14/2010SE |
| K100388 | 21ST Century Centurion Exceled and System Two LED Lighting SystemsFST · Traditional | Medical Illumination International, Inc. | 06/22/2010SE |
| K100395 | Harmony Vled Surgical Lightning SystemFST · Special | STERIS Corporation | 03/17/2010SE |
| K093386 | Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FSTFST · Traditional | Bfw, Inc. | 01/28/2010SE |
More from Bfw, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983277 | Lightsource or Illuminator Model I-100HBI · Traditional | 12/16/1998SE |
| K981962 | Cuda Products Corp. Model M300 (M-300) LightsourceFSS · Traditional | 08/18/1998SE |
| K981469 | CERMAX300 LightsourceFSS · Traditional | 07/09/1998SE |
| K980350 | Video Camera/Lightsource Combination Unit Model VCL-150GCJ · Traditional | 04/28/1998SE |
| K980166 | Lightsource or IlluminatorHET · Traditional | 04/01/1998SE |
| K961074 | Lightsource or IlluminatorFSS · Traditional | 04/30/1996SE |
| K951019 | Intraoral Video Scope and Window TubeEIA · Traditional | 05/10/1995SE |
| K943731 | Video OtoscopeERA · Traditional | 10/11/1994SE |
| K935818 | EndoscopeGDB · Traditional | 07/13/1994SE |
| K933369 | Cuda Products Corp. LightsourcesFCW · Traditional | 01/03/1994SE |
Questions and answers
When was Fiber Optic Light Guide or Fiber Optic Cable cleared by the FDA?
Fiber Optic Light Guide or Fiber Optic Cable (K901035) received a 510(k) decision of Substantially Equivalent on April 23, 1990, 48 days after the submission was received.
What is the product code of K901035?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.