FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
DUODERM HYDROACTIVE GEL
K Number: K973806
·
Decision Dec 29, 1997
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
10
Review Days
84
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Basic Information
- Device Name
- DUODERM HYDROACTIVE GEL
- K Number
- K973806
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Convatec, A Bristol-Myers Squibb Co.
- Date Received
- October 6, 1997
- Decision Date
- December 29, 1997
- 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 |
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TENDERWET ACTIVE
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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 |
| 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 |