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510(k) K141132

ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT by Biofilm, Inc. — Product Code PEB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2015
Date Received
May 1, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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.

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  • K200239 — Astroglide Organix Gel (November 13, 2020)
  • K200114 — Astroglide Organix Liquid (October 13, 2020)
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Other clearances for product code PEB

  • K212885 — Actively Trying Personal Lubricant Rose Scented (February 11, 2022)
  • K212705 — Actively Trying Personal Lubricant Unfragrance (February 9, 2022)
  • K193450 — Pre-Seed™ Fertility Lubricant (July 23, 2020)
  • K190872 — BioGenesis Fertility Lubricant (November 7, 2019)
  • K182585 — JO Actively Trying Personal Lubricant (April 26, 2019)
  • K162319 — BabyDance Fertility Lubricant (April 28, 2017)
  • K131355 — CONCEIVE PLUS (November 7, 2013)
  • K072741 — PRE-VA VAGINAL LUBRICANT (July 16, 2008)
  • K051436 — PRE' VAGINAL LUBRICANT (October 13, 2006)