KAI — Mirror, Ent Class I

FDA Device Classification

FDA product code KAI covers "Mirror, Ent", a Class I medical device regulated under 21 CFR 874.4420. Submissions are reviewed by the Ear, Nose, Throat panel. At least 9 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KAI
Device Class
Class I
Regulation Number
874.4420
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K833601microtek medicalANTRUM & ATTIC MIRRORJanuary 3, 1984
K823915treace medicalMIRROR TIPJanuary 21, 1983
K822374treace medicalBUCKINGHAM ATTIC & ANTRUM MIRRORSeptember 9, 1982
K822261kelleherLARYNGEAL MIRRORSAugust 30, 1982
K822191kelleherHEAD MIRROR WITH HEADBANDAugust 20, 1982
K820354jedmed instrumentATMOS MIRROR WARMERMarch 1, 1982
K781750arleton technical productsMIRROR WARMERJanuary 17, 1979
K770053welch allynMIRROR, LARYNGEALJanuary 18, 1977
K770054welch allynMIRROR, NASO-PHARYNXJanuary 18, 1977