FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XL-4 PAGODA (CONDOMS)
K Number: K874851
·
Decision Jan 21, 1988
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
398
Applicant Total
16
Review Days
57
Basic Information
- Device Name
- XL-4 PAGODA (CONDOMS)
- K Number
- K874851
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- MAYER LABORATORIES
- Date Received
- November 25, 1987
- Decision Date
- January 21, 1988
- Product Code
- HIS
- 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 |
|---|---|---|---|
| HIS | Condom | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIS), ordered by most recent decision date.
Natural rubber latex male condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Lelo Hex Lubricated Natural Rubber Latex Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
0.04 ZERO ZERO FOUR Male Latex Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LifeStyles NRL Textured Condom
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by MAYER LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K001974 | EZ-ON CONDOM | Oct 24, 2001 | Substantially Equivalent |
| K946374 | KIMONO MICROTHIN | Nov 8, 1995 | Substantially Equivalent |
| K943064 | KIMONO (CONDOMS) | Sep 22, 1995 | Substantially Equivalent |
| K946376 | MAXX | Sep 22, 1995 | Substantially Equivalent |
| K925869 | SHEATHES, STERILE SHEATHES | Jan 6, 1994 | Substantially Equivalent |
| K926049 | DIGITEX, DIGITEX HYPOALLERGENIC | Jul 22, 1993 | Substantially Equivalent |
| K904375 | KIMONO PLUS | Nov 26, 1990 | Substantially Equivalent |
| K904453 | LABELLING MODIFICATION TO MAXX PLUS | Nov 23, 1990 | Substantially Equivalent |
| K904840 | ORION PLUS/MODIFICATION | Nov 20, 1990 | Substantially Equivalent |
| K895530 | STANDARD CONDOM | Nov 28, 1989 | Substantially Equivalent |