FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
K Number: K183384
·
Decision Mar 4, 2019
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
14
Review Days
88
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Basic Information
- Device Name
- JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
- K Number
- K183384
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- United Consortium
- Date Received
- December 6, 2018
- Decision Date
- March 4, 2019
- 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 United Consortium
| K Number | Device Name | ||
|---|---|---|---|
| K192203 | JO for Him H2O Gel Original Personal Lubricant | Feb 10, 2020 | Substantially Equivalent |
| K190858 | Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant | Sep 18, 2019 | Substantially Equivalent |
| K191214 | JO Premium Jelly Original Personal Lubricant | Aug 1, 2019 | Substantially Equivalent |
| K182585 | JO Actively Trying Personal Lubricant | Apr 26, 2019 | Substantially Equivalent |
| K183584 | JO H2O Jelly Original Personal Lubricant | Apr 17, 2019 | Substantially Equivalent |
| K182105 | JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant | Nov 14, 2018 | Substantially Equivalent |
| K181408 | JO Classic Hybrid Personal Lubricant | Aug 27, 2018 | Substantially Equivalent |
| K180712 | Coconut Infused Hybrid Personal Lubricant | Jun 6, 2018 | Substantially Equivalent |
| K180219 | JO H2O Flavored Personal Lubricants | Apr 20, 2018 | Substantially Equivalent |
| K180083 | Silicone Personal Lubricant, ALL-IN-ONE | Apr 9, 2018 | Substantially Equivalent |