FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BioNude Lubricant
K Number: K180136
·
Decision Jun 1, 2018
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
7
Review Days
135
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Basic Information
- Device Name
- BioNude Lubricant
- K Number
- K180136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Good Clean Love, Inc.
- Date Received
- January 17, 2018
- Decision Date
- June 1, 2018
- 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
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Other Clearances by Good Clean Love, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K242162 | Coconut Hybrid | Sep 19, 2024 | Substantially Equivalent |
| K211998 | Desnuda Reflect | Nov 18, 2021 | Substantially Equivalent |
| K212000 | Medley | Nov 18, 2021 | Substantially Equivalent |
| K193448 | BioNourish Lubricant | Mar 12, 2020 | Substantially Equivalent |
| K190872 | BioGenesis Fertility Lubricant | Nov 7, 2019 | Substantially Equivalent |
| K150094 | Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla | Nov 19, 2015 | Substantially Equivalent |