FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Synthetic Polyisoprene Lubricated Male Condom - 5 senses
K Number: K182438
·
Decision Dec 6, 2018
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
2
Review Days
90
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Basic Information
- Device Name
- Synthetic Polyisoprene Lubricated Male Condom - 5 senses
- K Number
- K182438
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sxwell USA, LLC
- Date Received
- September 7, 2018
- Decision Date
- December 6, 2018
- Product Code
- MOL
- 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 |
|---|---|---|---|
| MOL | Condom, Synthetic | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Sxwell USA, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K172473 | LifeStyles® SKYN® Intimate Moments Personal Lubricant | Dec 15, 2017 | Substantially Equivalent |