FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
K Number: K041779
·
Decision Sep 21, 2004
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
27
Review Days
82
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Basic Information
- Device Name
- NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L
- K Number
- K041779
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corp.
- Date Received
- July 1, 2004
- Decision Date
- September 21, 2004
- Product Code
- FMG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K063721 | NIPRO SAFETOUCH II GAMMA | Jan 12, 2007 | Substantially Equivalent |
| K052474 | NIPRO HYPODERMIC NEEDLE | Nov 10, 2005 | Substantially Equivalent |
| K051574 | NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE | Aug 26, 2005 | Substantially Equivalent |
| K032777 | MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE | Nov 14, 2003 | Substantially Equivalent |
| K030683 | NIPRO DISPOSABLE SYRINGES | Oct 31, 2003 | Substantially Equivalent |
| K022756 | NIPRO BIO-FLEX CATHETER | Oct 18, 2002 | Substantially Equivalent |