FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONQUEST MALE CONTINENCE SYSTEM
K Number: K942941
·
Decision Mar 17, 1995
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
21
Applicant Total
10
Review Days
268
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Basic Information
- Device Name
- CONQUEST MALE CONTINENCE SYSTEM
- K Number
- K942941
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Convatec, A Bristol-Myers Squibb Co.
- Date Received
- June 22, 1994
- Decision Date
- March 17, 1995
- Product Code
- EXJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EXJ | Device, Incontinence, Urosheath Type, Sterile | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXJ), ordered by most recent decision date.
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PROSYS SAMEC LA
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SELF RETAINING MALE EXTERNAL URINARY CATHETER
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FDA Class 1
·Gastroenterology, Urology
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Convatec, A Bristol-Myers Squibb Co.
| K Number | Device Name | ||
|---|---|---|---|
| K032734 | CONVATEC FECAL MANAGEMENT SYSTEM | Apr 8, 2004 | Substantially Equivalent |
| K990368 | DUODERM HYDROACTIVE GEL WOUND DRESSING | Mar 26, 1999 | Substantially Equivalent |
| K982116 | AQUACEL HYDROFIBER WOUND DRESSING | Sep 8, 1998 | Substantially Equivalent |
| K973806 | DUODERM HYDROACTIVE GEL | Dec 29, 1997 | Substantially Equivalent for Some Indications |
| K973807 | DUODERM HYDROACTIVE PASTE | Dec 23, 1997 | Substantially Equivalent for Some Indications |
| K973716 | DUODERM EXTRA THIN CGF DRESSING | Dec 17, 1997 | Substantially Equivalent for Some Indications |
| K973717 | COMBIDERM ACD | Dec 17, 1997 | Substantially Equivalent for Some Indications |
| K954918 | COMBIDERM ACD | Dec 26, 1995 | Substantially Equivalent |
| K940895 | EPIVIEW | Nov 22, 1994 | Substantially Equivalent for Some Indications |