FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
ENVISAN PASTE
K Number: K874553
·
Decision Dec 18, 1987
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
21
Applicant Total
38
Review Days
44
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
- ENVISAN PASTE
- K Number
- K874553
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4018
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Marion Laboratories, Inc.
- Date Received
- November 4, 1987
- Decision Date
- December 18, 1987
- Product Code
- KOZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOZ), ordered by most recent decision date.
INCARE PINSITE DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CUTINOVA HYDRO
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
IODOSORB GEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
REDI-RELEASE ABSORBENT DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIOCLUSIVE(R) ABSORBENT DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
DERMASORB WOUND CONTACT LAYER DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Marion Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883391 | POLYMER ADHESIVE BANDAGE | Mar 23, 1989 | Substantially Equivalent for Some Indications |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Jul 5, 1988 | Substantially Equivalent |
| K875181 | MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM | May 27, 1988 | Substantially Equivalent |
| K874554 | ENVICLUSIVE (TM) | Mar 11, 1988 | Substantially Equivalent |
| K874551 | ENVINET(TM) | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K874552 | ENVISAN PAD | Jan 22, 1988 | Substantially Equivalent for Some Indications |
| K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST | Apr 14, 1987 | Substantially Equivalent |
| K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST | Sep 17, 1986 | Substantially Equivalent |
| K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE | Jun 16, 1986 | Substantially Equivalent |
| K853073 | CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. | Aug 1, 1985 | Substantially Equivalent |