510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OGRClass I

Ear, Nose, And Throat Surgical Tray

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

OGR is the FDA product code for Ear, Nose, And Throat Surgical Tray, a class I device type, regulated under 21 CFR 874.4420. FDA's definition for this code reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket...". As of , FDA records hold no 510(k) clearances under this code and 74 recalls.

Classification record

Product code
OGR
Device name
Ear, Nose, And Throat Surgical Tray
FDA definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
76

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order