DeviceClearance

Product code EOX— Ear, Nose, Throat

Cytosponge Cell Collection Device

Classification name
Esophagoscope (Flexible Or Rigid)
Device class
Class 2
Regulation
21 CFR 874.4710
Advisory panel
Ear, Nose, Throat
Total cleared
30
First cleared
Most recent

FDA classification definition

“If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

— U.S. Food and Drug Administration, device classification record for product code EOX under 21 CFR 874.4710, via openFDA

Market context for product code EOX

FDA has cleared 30 devices under product code EOX between 1976 and 2024, filed by 16 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 EOX

Recent clearances under product code EOX

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