FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Astroglide Glycerin & Paraben Free
K Number: K220653
·
Decision May 6, 2022
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
17
Review Days
60
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Basic Information
- Device Name
- Astroglide Glycerin & Paraben Free
- K Number
- K220653
- 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
- March 7, 2022
- Decision Date
- May 6, 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 |
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Other Clearances by Biofilm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221036 | Astroglide Warming | Jul 1, 2022 | Substantially Equivalent |
| K220355 | Astroglide Ultra Gentle Gel | May 26, 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 |
| K200114 | Astroglide Organix Liquid | Oct 13, 2020 | Substantially Equivalent |
| K171985 | Astroglide O Oil Personal Lubricant & Massage Oil | Aug 30, 2017 | Substantially Equivalent |
| K163395 | Astroglide Diamond Silicone Gel Personal Lubricant | Feb 10, 2017 | Substantially Equivalent |
| K141132 | ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT | Jan 9, 2015 | Substantially Equivalent |
| K140590 | ASTROGLIDE SENSUAL STRAWBERRY | Oct 30, 2014 | Substantially Equivalent |