DeviceClearance

Product code JOF— Ear, Nose, Throat

BIOSPONGE RECONSTRUCTION DISCS

Classification name
Polymer, Ent Synthetic, Porous Polyethylene
Device class
Class 2
Regulation
21 CFR 874.3620
Advisory panel
Ear, Nose, Throat
Total cleared
6
First cleared
Most recent

Market context for product code JOF

FDA has cleared 6 devices under product code JOF between 1977 and 2020, 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

Top applicants under product code JOF

Recent clearances under product code JOF

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