Product code LWI— Radiology
CPR GENERAL SURGERY TRAY
- Classification name
- Ultrasound, Sinus
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code LWI
FDA has cleared devices under product code LWI between 1987 and 1997, filed by 4 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
- 1996
- 1987
Top applicants under product code LWI
Recent clearances under product code LWI
Data sourced from openFDA. This site is unofficial and independent of the FDA.