FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
K Number: K100520
·
Decision Mar 17, 2010
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
34
Review Days
22
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Basic Information
- Device Name
- NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
- K Number
- K100520
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corporation
- Date Received
- February 23, 2010
- Decision Date
- March 17, 2010
- 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.
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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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JMS Harmony A.V. Fistula Needle Set
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ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
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FDA Class 2
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