FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEEDLE, DIALYSIS
K Number: K902564
·
Decision Mar 1, 1991
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
13
Review Days
263
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Basic Information
- Device Name
- NEEDLE, DIALYSIS
- K Number
- K902564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Gainor Medical Europe, Ltd.
- Date Received
- June 11, 1990
- Decision Date
- March 1, 1991
- Product Code
- FIE
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
JMS CAVEO A.V. Fistula Needle Set
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DORA Disposable A.V. Fistula Needle Sets
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Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
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DORA Disposable A.V. Fistula Needle Sets
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·Gastroenterology, Urology
JMS Harmony A.V. Fistula Needle Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Gainor Medical Europe, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K926448 | I.V. ADMINISTRATION SET | May 2, 1994 | Substantially Equivalent |
| K931828 | CARELET SAFETY LANCET | Oct 15, 1993 | Substantially Equivalent |
| K931827 | CLEANLET, CLEANLET XL & KIDS | Sep 13, 1993 | Substantially Equivalent |
| K922441 | SURESEAL BANDAGE | Aug 10, 1993 | Substantially Equivalent |
| K913333 | I.V. PRIMING SET | Oct 23, 1991 | Substantially Equivalent |
| K902422 | NEEDLE, ASPIRATION & INJECTION, DISPOSABLE | Jun 6, 1991 | Substantially Equivalent |
| K902420 | CATHETER, NASAL, OXYGEN | Apr 17, 1991 | Substantially Equivalent |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | Nov 20, 1990 | Substantially Equivalent |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | Nov 20, 1990 | Substantially Equivalent |
| K902416 | SURELITE AND SURELITE XL BLOOD LANCET | Aug 1, 1990 | Substantially Equivalent |