FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Astroglide Ultra Gentle Gel
K Number: K220355
·
Decision May 26, 2022
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
230
Applicant Total
7
Review Days
107
Basic Information
- Device Name
- Astroglide Ultra Gentle Gel
- K Number
- K220355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BioFilm Inc.
- Date Received
- February 8, 2022
- Decision Date
- May 26, 2022
- Product Code
- NUC
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUC | Lubricant, Personal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUC), ordered by most recent decision date.
LubriZenzs
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Water Solubility Human Body Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sutil Rich Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Joylux Intimacy Gel (PG3100)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by BioFilm Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221036 | Astroglide Warming | Jul 1, 2022 | Substantially Equivalent |
| K220653 | Astroglide Glycerin & Paraben Free | May 6, 2022 | Substantially Equivalent |
| K213671 | Astroglide Sensual Strawberry Personal Lubricant | Mar 3, 2022 | Substantially Equivalent |
| K210242 | Astroglide X Silicone Personal Lubricant | Apr 28, 2021 | Substantially Equivalent |
| K200239 | Astroglide Organix Gel | Nov 13, 2020 | Substantially Equivalent |
| K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Aug 30, 2017 | Substantially Equivalent |