DeviceClearance

Product code KHJ— Ear, Nose, Throat

Biodesign Otologic Repair Graft

Classification name
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Device class
Class 2
Regulation
21 CFR 874.3620
Advisory panel
Ear, Nose, Throat
Total cleared
34
First cleared
Most recent

Market context for product code KHJ

FDA has cleared 34 devices under product code KHJ between 1991 and 2026, filed by 19 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

last 15 years

Top applicants under product code KHJ

Recent clearances under product code KHJ

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