DeviceClearance

Product code EOB— Ear, Nose, Throat

ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE

Classification name
Nasopharyngoscope (Flexible Or Rigid)
Device class
Class 2
Regulation
21 CFR 874.4760
Advisory panel
Ear, Nose, Throat
Total cleared
162
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 EOB under 21 CFR 874.4760, via openFDA

Market context for product code EOB

FDA has cleared 162 devices under product code EOB between 1987 and 2026, filed by 87 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 EOB

Adverse events under product code EOB

product code EOB
Malfunction
6,143
Total
6,143

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code EOB

1–100 of 162

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