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

Kit, Conception-Assist, Home Use

21 CFR 884.5250 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

OBB is the FDA product code for Kit, Conception-Assist, Home Use, a class II device type, regulated under 21 CFR 884.5250. FDA's definition for this code reads: "The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OBB
Device name
Kit, Conception-Assist, Home Use
FDA definition
The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for more than 6 hours. The kit consists of: conception (cervical) caps; 3 polyurethane condoms; 24 ovulation predictors; 3 pregnancy test kits; 3 "sperm friendly" moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope.
Regulation
21 CFR 884.5250
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code OBB

By decision year
4 clearances under product code OBB with a decision year between 2007 and 2014, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OBB by decision year
YearClearances
20071
20081
20121
20141

Applicants with the most clearances

Product code OBB
Applicants holding the most 510(k) clearances under product code OBB
ApplicantClearances
Conceivex, Inc.2
Intimate Bridge 2 Conception, Inc.1
Rinovum Subsidiary 2, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code