FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONVATEC ABSORBENT BANDAGE
K Number: K904233
·
Decision Mar 6, 1991
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
2
Applicant Total
81
Review Days
182
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Basic Information
- Device Name
- CONVATEC ABSORBENT BANDAGE
- K Number
- K904233
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
- Date Received
- September 5, 1990
- Decision Date
- March 6, 1991
- Product Code
- EXE
- 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 |
|---|---|---|---|
| EXE | Protector, Ostomy | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXE), ordered by most recent decision date.
UNITED SKIN BARRIER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
STOMA SHIELD ADAPTER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Other Clearances by Convatec, A Division of E.R. Squibb & Sons
| K Number | Device Name | ||
|---|---|---|---|
| K013814 | ABSORBENT ANTIMICROBIAL WOUND DRESSING | Jun 21, 2002 | Substantially Equivalent |
| K990964 | SIGNADRESS DUODERM DRESSING | May 18, 1999 | Substantially Equivalent |
| K984388 | HA ABSORBENT WOUND DRESSING | Mar 3, 1999 | Substantially Equivalent |
| K980720 | NONWOVEN PAD | Apr 15, 1998 | Substantially Equivalent |
| K980382 | NON-WOVEN COMPRESS | Mar 9, 1998 | Substantially Equivalent for Some Indications |
| K974823 | NONWOVEN DRESSING | Feb 20, 1998 | Substantially Equivalent for Some Indications |
| K974205 | KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON | Feb 6, 1998 | Substantially Equivalent |
| K974304 | GERMICIDAL CLOTH | Jan 13, 1998 | Substantially Equivalent |
| K973632 | DUODERM CGF CONTROL GEL FORMULA DRESSING | Dec 22, 1997 | Substantially Equivalent for Some Indications |
| K972530 | CONVATEC ODOR CONTROL WOUND DRESSING | Oct 1, 1997 | Substantially Equivalent |