Product code FTI— Gastroenterology, Urology
CLARUS MODEL 5197 SIGHTLITE
- Classification name
- Lamp, Endoscope, Incandescent
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code FTI
FDA has cleared devices under product code FTI between 1992 and 1997, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1997
- 1992
Top applicants under product code FTI
Recent clearances under product code FTI
Data sourced from openFDA. This site is unofficial and independent of the FDA.