510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PEBClass II

Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible

21 CFR 884.5300 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PEB is the FDA product code for Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible, a class II device type, regulated under 21 CFR 884.5300. FDA's definition for this code reads: "A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device...". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PEB
Device name
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
FDA definition
A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.
Regulation
21 CFR 884.5300
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
10
Ingested recalls
0

Clearances, product code PEB

By decision year
10 clearances under product code PEB with a decision year between 2006 and 2022, 2019 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PEB by decision year
YearClearances
20061
20081
20131
20151
20171
20192
20201
20222

Applicants with the most clearances

Product code PEB
Applicants holding the most 510(k) clearances under product code PEB
ApplicantClearances
CC Wellness LLC2
Biofilm, Inc.1
Church & Dwight Co., Inc.1
Fairhaven Health1
Good Clean Love, Inc.1
Ingfertility, LLC1
Ingfertlity, LLC1
Sasmar, Inc.1
United Consortium1

Companies listing this code with FDA

Companies whose registered establishments list this code