FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DUODERM HYDROACTIVE GEL WOUND DRESSING
K Number: K990368
·
Decision Mar 26, 1999
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
10
Review Days
46
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
- DUODERM HYDROACTIVE GEL WOUND DRESSING
- K Number
- K990368
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Convatec, A Bristol-Myers Squibb Co.
- Date Received
- February 8, 1999
- Decision Date
- March 26, 1999
- Product Code
- MGQ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MGQ), ordered by most recent decision date.
HylaGuard Moisturizing Cream
FDA 510(k)
FDA Unclassified
·Unknown
HYLATOPIC EMOLLIENT FOAM
FDA 510(k)
FDA Unclassified
·Unknown
IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
FDA 510(k)
FDA Unclassified
·Unknown
SILVERSITE OR CALGITROL
FDA 510(k)
FDA Unclassified
·Unknown
SILVERSEAL
FDA 510(k)
FDA Unclassified
·Unknown
TENDERWET ACTIVE
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Convatec, A Bristol-Myers Squibb Co.
| K Number | Device Name | ||
|---|---|---|---|
| K032734 | CONVATEC FECAL MANAGEMENT SYSTEM | Apr 8, 2004 | 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 |
| K942941 | CONQUEST MALE CONTINENCE SYSTEM | Mar 17, 1995 | Substantially Equivalent |
| K940895 | EPIVIEW | Nov 22, 1994 | Substantially Equivalent for Some Indications |