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OGSClass II

Myringotomy Procedure Kit

21 CFR 874.3880 / Ear, Nose, Throat
FDA source (opens on fda.gov)

OGS is the FDA product code for Myringotomy Procedure Kit, a class II device type, regulated under 21 CFR 874.3880. 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 one recall.

Classification record

Product code
OGS
Device name
Myringotomy Procedure Kit
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 874.3880
Device class
Class II
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
1

Companies listing this code with FDA

Companies whose registered establishments list this code