DeviceClearance

Product code ESF— General, Plastic Surgery

BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC

Classification name
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
Device class
Class 2
Regulation
21 CFR 878.3500
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

Market context for product code ESF

FDA has cleared 2 devices under product code ESF between 1982 and 1989, 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

Top applicants under product code ESF

Recent clearances under product code ESF

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