DeviceClearance

Product code PEB— Obstetrics/Gynecology

ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT

Classification name
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Device class
Class 2
Regulation
21 CFR 884.5300
Advisory panel
Obstetrics/Gynecology
Total cleared
10
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PEB under 21 CFR 884.5300, via openFDA

Market context for product code PEB

FDA has cleared 10 devices under product code PEB between 2006 and 2022, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PEB

Recent clearances under product code PEB

Data sourced from openFDA. This site is unofficial and independent of the FDA.