Cuda Products Corp. Model MX2-300 Lightsource
FDA 510(k) K934337 · Cuda Products Co.
510(k) numberK934337
Submission
- Device name
- Cuda Products Corp. Model MX2-300 Lightsource
- Applicant
- Cuda Products Co.
Jacksonville, FL, US - Received
- September 7, 1993
- Decision date
- November 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FSW – Light, Surgical, Endoscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSW
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|---|---|---|---|
| K022989 | Radlite Tissue Retractor SystemFSW · Traditional | Genzyme Biosurgery | 11/25/2002SE |
| K013511 | Xenalight Models # AX9125 (100-120V~); # AX9225 (220-240V~)FSW · Traditional | Aculux, Inc. | 02/01/2002SE |
| K943342 | Medicam Xenon Light SourceFSW · Traditional | M.P. Video, Inc. | 10/17/1994SE |
| K922279 | Illuminator IV Minor Surgery LightFSW · Traditional | Medical Illumination, Inc. | 09/02/1992SE |
| K913135 | LM-300TWINFSW · Traditional | Leisegang Medical, Inc. | 09/18/1991SE |
| K894319 | Medical Dynamics Light SourceFSW · Traditional | Medical Dynamics, Inc. | 10/03/1989SE |
| K870898 | Ultra-Lux Light SourceFSW · Traditional | Medline Industries, Inc. | 03/18/1987SE |
More from Medline Industries, 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 Cuda Products Corp. Model MX2-300 Lightsource cleared by the FDA?
Cuda Products Corp. Model MX2-300 Lightsource (K934337) received a 510(k) decision of Substantially Equivalent on November 18, 1993, 72 days after the submission was received.
What is the product code of K934337?
The FDA product code is FSW – Light, Surgical, Endoscopic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.