FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLISSANT Intimate Lubricant
K Number: K183050
·
Decision Jul 8, 2019
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
1
Review Days
248
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GLISSANT Intimate Lubricant
- K Number
- K183050
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vjuvenate, LLC
- Date Received
- November 2, 2018
- Decision Date
- July 8, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUC), ordered by most recent decision date.
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
pjur NATURE Touch, 100 ml
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Julva Velvé Water-Based Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Water-based lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology