Product code ESX— Ear, Nose, Throat

CODY SACCULOTOMY TACK

Classification name
Tack, Sacculotomy (Cody Tack)
Device class
Class 2
Regulation
21 CFR 874.3760
Advisory panel
Ear, Nose, Throat
Total cleared
1
First cleared
Most recent

Market context for product code ESX

FDA has cleared 1 device under product code ESX, all in 1983, 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 ESX

Recent clearances under product code ESX

Data sourced from openFDA. This site is unofficial and independent of the FDA.