Product code LYN— Ear, Nose, Throat

SENSICARE SYNTHETIC, SURGICAL GLOVE LINER

Classification name
Apparatus, Visual Reinforcement Audiometric
Device class
Class 2
Regulation
21 CFR 874.1050
Advisory panel
Ear, Nose, Throat
Total cleared
3
First cleared
Most recent

Market context for product code LYN

FDA has cleared 3 devices under product code LYN between 1989 and 1995, filed by 3 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 LYN

Recent clearances under product code LYN

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