Lightsource or Illuminator
FDA 510(k) K980166 · Cuda Products Co.
510(k) numberK980166
Submission
- Device name
- Lightsource or Illuminator
- Applicant
- Cuda Products Co.
Jacksonville, FL, US - Received
- January 16, 1998
- Decision date
- April 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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More from 270surgical , Ltd.
| 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 |
| 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 |
| K934337 | Cuda Products Corp. Model MX2-300 LightsourceFSW · Traditional | 11/18/1993SE |
Questions and answers
When was Lightsource or Illuminator cleared by the FDA?
Lightsource or Illuminator (K980166) received a 510(k) decision of Substantially Equivalent on April 1, 1998, 75 days after the submission was received.
What is the product code of K980166?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.