DeviceClearance

Product code EQN— Ear, Nose, Throat

CONPHAR LARYNGOSCOPE

Classification name
Laryngoscope, Nasopharyngoscope
Device class
Class 2
Regulation
21 CFR 874.4760
Advisory panel
Ear, Nose, Throat
Total cleared
22
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 EQN under 21 CFR 874.4760, via openFDA

Market context for product code EQN

FDA has cleared 22 devices under product code EQN between 1977 and 2026, filed by 13 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 EQN

Recent clearances under product code EQN

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