FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
PRIMAPORE I.V.
K Number: K893900
·
Decision Aug 3, 1989
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
34
Review Days
48
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
- PRIMAPORE I.V.
- K Number
- K893900
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Smith & Nephew United, Inc.
- Date Received
- June 16, 1989
- Decision Date
- August 3, 1989
- Product Code
- KGX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
FDA 510(k)
FDA Class 1
·General Hospital
CARE BAND ANTIBACTERIAL BANDAGES
FDA 510(k)
FDA Class 1
·General Hospital
SYVEK PATCH
FDA 510(k)
FDA Class 1
·General Hospital
ADHESIVE BANDAGES WITH OTC DRUG
FDA 510(k)
FDA Class 1
·General Hospital
TARGETT PATCH
FDA 510(k)
FDA Class 1
·General Hospital
PARALLEL
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Smith & Nephew United, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K963096 | ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING | Oct 25, 1996 | Substantially Equivalent |
| K961775 | PROFORE FOUR-LAYER BANDAGE SYSTEM KIT | Jul 16, 1996 | Substantially Equivalent |
| K945330 | ALLEVYN ADHESIVE | Feb 9, 1995 | Substantially Equivalent for Some Indications |
| K943619 | CAVI-CARE CONFORMING FOAM DRESSING | Aug 19, 1994 | Substantially Equivalent for Some Indications |
| K942748 | INTRASITE | Jun 29, 1994 | Substantially Equivalent for Some Indications |
| K935705 | ALLEVYN ISLAND WOUND DRESSING | Feb 15, 1994 | Substantially Equivalent |
| K935803 | CICA-CARE SILICONE GEL SHEET | Feb 3, 1994 | Substantially Equivalent |
| K932263 | SOLOSITE DERMAL WOUND GEL | Oct 1, 1993 | Substantially Equivalent |
| K926508 | INTRASITE GEL | Jul 13, 1993 | Substantially Equivalent |
| K922897 | STRAPPAL | Sep 15, 1992 | Substantially Equivalent |