Astroglide Organix Gel
FDA 510(k) K200239 · Biofilm, Inc.
510(k) numberK200239
Submission
- Device name
- Astroglide Organix Gel
- Applicant
- Biofilm, Inc.
Vista, CA, US - Received
- January 31, 2020
- Decision date
- November 13, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUC – Lubricant, Personal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.
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| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
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| K254011 | Flow Water-Based Personal LubricantNUC · Traditional | LBDO Group, Inc. | 06/22/2026SE |
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| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional | Hathor Professional Skincare , Ltd. | 06/09/2026SE |
| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | Pjur Group Luxembourg S.A. | 05/21/2026SE |
| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional | Hudi Pharma Srl | 04/01/2026SE |
More from Hudi Pharma Srl
| 510(k) | Device | Decision |
|---|---|---|
| K221036 | Astroglide WarmingNUC · Traditional | 07/01/2022SE |
| K220355 | Astroglide Ultra Gentle GelNUC · Traditional | 05/26/2022SE |
| K220653 | Astroglide Glycerin & Paraben FreeNUC · Traditional | 05/06/2022SE |
| K213671 | Astroglide Sensual Strawberry Personal LubricantNUC · Traditional | 03/03/2022SE |
| K210242 | Astroglide X Silicone Personal LubricantNUC · Traditional | 04/28/2021SE |
| K200114 | Astroglide Organix LiquidNUC · Traditional | 10/13/2020SE |
| K171985 | Astroglide O Oil Personal Lubricant & Massage OilNUC · Traditional | 08/30/2017SE |
| K163395 | Astroglide Diamond Silicone Gel Personal LubricantNUC · Traditional | 02/10/2017SE |
| K141132 | Astroglide TTC Fertility Friendly Personal LubricantPEB · Traditional | 01/09/2015SE |
| K140590 | Astroglide Sensual StrawberryNUC · Traditional | 10/30/2014SE |
Questions and answers
When was Astroglide Organix Gel cleared by the FDA?
Astroglide Organix Gel (K200239) received a 510(k) decision of Substantially Equivalent on November 13, 2020, 287 days after the submission was received.
What is the product code of K200239?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.