DeviceClearance

Product code EOQ— Ear, Nose, Throat

Ion Endoluminal System (IF1000)

Classification name
Bronchoscope (Flexible Or Rigid)
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Total cleared
241
First cleared
Most recent

FDA classification definition

“A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. 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 EOQ under 21 CFR 874.4680, via openFDA

Market context for product code EOQ

FDA has cleared 241 devices under product code EOQ between 1976 and 2026, filed by 102 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 EOQ

Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

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 EOQ

1–100 of 241

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