Product code KLZ— Ear, Nose, Throat
EASY-JET DEVICE
- Classification name
- Tube, Shunt, Endolymphatic With Valve
- Device class
- Class 2
- Regulation
- 21 CFR 874.3850
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code KLZ
FDA has cleared device under product code KLZ, all in 1999, filed by 1 applicant company. 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.
Top applicants under product code KLZ
Recent clearances under product code KLZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.