Conceive Plus
FDA 510(k) K131355 · Sasmar, Inc.
510(k) numberK131355
Submission
- Device name
- Conceive Plus
- Applicant
- Sasmar, Inc.
Chicago, IL, US - Received
- May 10, 2013
- Decision date
- November 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEB – Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
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…
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|---|---|---|---|
| K212885 | Actively Trying Personal Lubricant Rose ScentedPEB · Traditional | CC Wellness, LLC | 02/11/2022SE |
| K212705 | Actively Trying Personal Lubricant UnfragrancePEB · Traditional | CC Wellness, LLC | 02/09/2022SE |
| K193450 | Pre-Seed Fertility LubricantPEB · Traditional | Church & Dwight Co., Inc. | 07/23/2020SE |
| K190872 | BioGenesis Fertility LubricantPEB · Traditional | Good Clean Love, Inc. | 11/07/2019SE |
| K182585 | JO Actively Trying Personal LubricantPEB · Traditional | United Consortium | 04/26/2019SE |
| K162319 | BabyDance Fertility LubricantPEB · Traditional | Fairhaven Health, LLC | 04/28/2017SE |
| K141132 | Astroglide TTC Fertility Friendly Personal LubricantPEB · Traditional | Biofilm, Inc. | 01/09/2015SE |
| K072741 | Pre-Va Vaginal LubricantPEB · Traditional | Ingfertility, LLC | 07/16/2008SE |
| K051436 | Pre' Vaginal LubricantPEB · Traditional | Ingfertlity, LLC | 10/13/2006SE |
More from Ingfertlity, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K131084 | Sasmar Original, Sasmar ClassicNUC · Traditional | 09/13/2013SE |
Questions and answers
When was Conceive Plus cleared by the FDA?
Conceive Plus (K131355) received a 510(k) decision of Substantially Equivalent on November 7, 2013, 181 days after the submission was received.
What is the product code of K131355?
The FDA product code is PEB – Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible, a Class II (moderate risk) device regulated under 21 CFR 884.5300.