FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEX-I-GRASP
K Number: K854889
·
Decision Feb 21, 1986
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
16
Review Days
77
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Basic Information
- Device Name
- FLEX-I-GRASP
- K Number
- K854889
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Euro-Med Intl.
- Date Received
- December 6, 1985
- Decision Date
- February 21, 1986
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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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 |
| K854891 | KNIFE | 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 |