FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKIN CLOSURE
K Number: K840945
·
Decision Oct 31, 1984
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
34
Applicant Total
11
Review Days
240
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
- SKIN CLOSURE
- K Number
- K840945
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Gainor Medical
- Date Received
- March 5, 1984
- Decision Date
- October 31, 1984
- Product Code
- FPX
- 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 |
|---|---|---|---|
| FPX | Strip, Adhesive, Closure, Skin | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPX), ordered by most recent decision date.
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
FDA 510(k)
FDA Class 1
·General Hospital
DELPORE SKIN CLOSURE
FDA 510(k)
FDA Class 1
·General Hospital
DERMA SEAL
FDA 510(k)
FDA Class 1
·General Hospital
BIOSTRIP STERILE WOUND CLOSURE STRIP
FDA 510(k)
FDA Class 1
·General Hospital
DUKAL SKIN CLOSURE STRIP
FDA 510(k)
FDA Class 1
·General Hospital
SPYROFLEX WOUND CLOSURES
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Gainor Medical
| K Number | Device Name | ||
|---|---|---|---|
| K850100 | BLOOD LANCET | Jan 29, 1987 | Substantially Equivalent |
| K850150 | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED | Feb 21, 1985 | Substantially Equivalent |
| K844306 | GAINOR MEDICAL SYRINGE | Nov 30, 1984 | Substantially Equivalent |
| K844305 | GAINOR MEDICAL FLOWMAX NEEDLES | Nov 30, 1984 | Substantially Equivalent |
| K840951 | FIRST AID BANDAGE | Oct 31, 1984 | Substantially Equivalent |
| K840950 | ZINC OXIDE TAPE | Oct 31, 1984 | Substantially Equivalent |
| K840947 | CLOTH-HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840949 | CLEAR PLASTIC-HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840946 | MICROPOROUS HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840948 | CLEAR POROUS PLASTIC-HYPOALLERGENIC | Aug 14, 1984 | Substantially Equivalent |