FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KNIFE
K Number: K854891
·
Decision May 2, 1986
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
20
Applicant Total
16
Review Days
147
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Basic Information
- Device Name
- KNIFE
- K Number
- K854891
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Euro-Med Intl.
- Date Received
- December 6, 1985
- Decision Date
- May 2, 1986
- Product Code
- EMF
- 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 |
|---|---|---|---|
| EMF | Knife, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMF), ordered by most recent decision date.
MOUNTABLE ENDOSCOPIC BLADE
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MOUNTABLE ENDOSCOPIC KNIFE
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MICROSURGICAL KNIVES
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MICROSURGERY RAZOR BLADE HOLDER
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MICROSURGICAL SCARIFIER
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VAN-TEC ENDOPYELOTOMY KNIFE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Euro-Med Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K883884 | PROSTATIC CORE-CUT NEEDLE | Dec 5, 1988 | Substantially Equivalent |
| K882404 | KEVOR-CURETTE | Jul 8, 1988 | Substantially Equivalent |
| K854894 | SPOON | May 2, 1986 | Substantially Equivalent |
| K854890 | HOOK PROBE | May 2, 1986 | Substantially Equivalent |
| K854898 | ATLANTIC GRASPER | May 2, 1986 | Substantially Equivalent |
| K854895 | BASKET FORCEP | May 2, 1986 | Substantially Equivalent |
| K854901 | PACIFIC GRASPER | May 2, 1986 | Substantially Equivalent |
| K854897 | MAX-I-GRASP | May 2, 1986 | Substantially Equivalent |
| K854896 | HOOK SCISSOR | May 2, 1986 | Substantially Equivalent |
| K854889 | FLEX-I-GRASP | Feb 21, 1986 | Substantially Equivalent |