FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K-Y BRAND INTRIGUE
K Number: K062796
·
Decision Dec 8, 2006
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
242
Applicant Total
45
Review Days
80
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
- K-Y BRAND INTRIGUE
- K Number
- K062796
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Personal Products Co.
- Date Received
- September 19, 2006
- Decision Date
- December 8, 2006
- 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
Other Clearances by Personal Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K070545 | K-Y BRAND WARMING LIQUID | Mar 23, 2007 | Substantially Equivalent |
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Apr 30, 2001 | Substantially Equivalent |
| K990536 | O.B. TAMPON | Aug 31, 1999 | Substantially Equivalent |
| K991118 | O.B. APPLICATOR TAMPONS, O.B. TAMPONS | Jun 29, 1999 | Substantially Equivalent |
| K974629 | O.B. APPLICATOR AND NON-APPLICATOR TAMPONS | Feb 10, 1998 | Substantially Equivalent |
| K971589 | REACH ANTIBACTERIAL TOOTHBRUSH | Jul 24, 1997 | Substantially Equivalent |
| K970954 | O.B. APPLICATOR TAMPONS | Jun 10, 1997 | Substantially Equivalent |
| K961119 | CAREFREE PANTYLINERS | Apr 17, 1996 | Substantially Equivalent |
| K953638 | O.B. APPLICATOR TAMPONS | Oct 20, 1995 | Substantially Equivalent |
| K941863 | O.B. TAMPON | Jun 27, 1994 | Substantially Equivalent |