C-Lite
FDA 510(k) K841589 · Suncoast Medical Manufacturers, Inc.
510(k) numberK841589
Submission
- Device name
- C-Lite
- Applicant
- Suncoast Medical Manufacturers, Inc.
Mchenry, IL, US - Received
- April 18, 1984
- Decision date
- May 22, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYT – Light, Examination, Medical, Battery Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6350
- Specialty
- General Hospital
Other 510(k)s with product code KYT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K920782 | Olympic Trans-LiteKYT · Traditional | Olympic Medical Corp. | 03/27/1992SE |
| K841588 | Sun-Lite White SpotKYT · Traditional | Suncoast Medical Manufacturers, Inc. | 05/22/1984SE |
| K791001 | Penlight/Swab HolderKYT · Traditional | Concept, Inc. | 06/22/1979SE |
| K781228 | PenlightsKYT · Traditional | Abco Dealers, Inc. | 09/07/1978SE |
| K760972 | Tycos Diagnostic PenlightKYT · Traditional | Taylor Instrument Analytics Co. | 01/26/1977SE |
More from Taylor Instrument Analytics Co.
| 510(k) | Device | Decision |
|---|---|---|
| K841604 | Adjust-A-Temp High TemperatureGEI · Traditional | 12/07/1984SE |
| K841603 | Adjust-A-Temp MicroGEI · Traditional | 12/07/1984SE |
| K841509 | Replace-A-Tip Adjustable High Temp.GEI · Traditional | 12/07/1984SE |
| K841459 | Replace-A-Tip Adjust. Low Temp.-GEI · Traditional | 12/07/1984SE |
| K841591 | Pyro-TipGEI · Traditional | 10/31/1984SE |
| K840376 | Surg-A Stat Loop TipGEI · Traditional | 10/26/1984SE |
| K840387 | Surg-A-Stat Loop Tip 2GEI · Traditional | 07/23/1984SE |
| K840377 | Surg-A-Stat Cardiovascular TipGEI · Traditional | 07/23/1984SE |
| K840375 | Surg-A-Stat Loop Tip 15GEI · Traditional | 07/23/1984SE |
| K840370 | Surg-A-Stat Vasectomy TipGET · Traditional | 07/23/1984SE |
Questions and answers
When was C-Lite cleared by the FDA?
C-Lite (K841589) received a 510(k) decision of Substantially Equivalent on May 22, 1984, 34 days after the submission was received.
What is the product code of K841589?
The FDA product code is KYT – Light, Examination, Medical, Battery Powered, a Class I (low risk) device regulated under 21 CFR 880.6350.