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

Condom, Female, Animal Tissue

21 CFR 884.5330 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

OBY is the FDA product code for Condom, Female, Animal Tissue, a class III device type, regulated under 21 CFR 884.5330. FDA's definition for this code reads: "A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OBY
Device name
Condom, Female, Animal Tissue
FDA definition
A female condom is a sheath-like device that lines the vaginal wall and is inserted into the vagina prior to the initiation of coitus. It is indicated for contraceptive and prophylactic (preventing the transmission of sexually transmitted diseases) purposes.
Regulation
21 CFR 884.5330
Device class
Class III
Review panel
Obstetrics/Gynecology
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OBY.