FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROSTATIC CORE-CUT NEEDLE
K Number: K883884
·
Decision Dec 5, 1988
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
16
Review Days
83
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Basic Information
- Device Name
- PROSTATIC CORE-CUT NEEDLE
- K Number
- K883884
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Euro-Med Intl.
- Date Received
- September 13, 1988
- Decision Date
- December 5, 1988
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Euro-Med Intl.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K854889 | FLEX-I-GRASP | Feb 21, 1986 | Substantially Equivalent |