FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OP-SITE SKIN CLOSURE SUTURE ADHESIVE
K Number: K801884
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
34
Applicant Total
27
Review Days
64
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Basic Information
- Device Name
- OP-SITE SKIN CLOSURE SUTURE ADHESIVE
- K Number
- K801884
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Acme United Corp.
- Date Received
- August 7, 1980
- Decision Date
- October 10, 1980
- 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
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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 Acme United Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961323 | LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING | Jun 19, 1996 | Substantially Equivalent |
| K961452 | LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING | May 31, 1996 | Substantially Equivalent |
| K952565 | LYOFOAM EXTRA | Nov 14, 1995 | Substantially Equivalent for Some Indications |
| K895764 | MODIFIED LYOFOAM WOUND DRESSINGS | Sep 10, 1990 | Substantially Equivalent for Some Indications |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Jun 9, 1987 | Substantially Equivalent |
| K864084 | LYOFOAM C ODOR-ABSORBING DRESSING | Nov 21, 1986 | Substantially Equivalent for Some Indications |
| K860085 | LYOFOAM WOUND DRESSINGS | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K860818 | ONE TIME ENTERAL FEEDING BAG | May 15, 1986 | Substantially Equivalent |
| K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS | Apr 22, 1986 | Substantially Equivalent |
| K842186 | ACU-DERM TRANSPARENT WOUND DRESSING | Aug 24, 1984 | Substantially Equivalent |