FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUOVOGUARD
K Number: K090122
·
Decision Feb 5, 2009
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
7
Review Days
15
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Basic Information
- Device Name
- NUOVOGUARD
- K Number
- K090122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- U.S. Safety Syringes Co., Inc.
- Date Received
- January 21, 2009
- Decision Date
- February 5, 2009
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by U.S. Safety Syringes Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090502 | NOVA SAFE SCALP VEIN BLOOD COLLECTION SET | Mar 10, 2009 | Substantially Equivalent |
| K083454 | NUOVOCATH | Dec 4, 2008 | Substantially Equivalent |
| K080665 | NOVOLET | May 13, 2008 | Substantially Equivalent |
| K080660 | IV ADMINISTRATION SET | May 13, 2008 | Substantially Equivalent |
| K003381 | SHIELDING NEEDLE HOLDER | Apr 23, 2001 | Substantially Equivalent |
| K990831 | SUPERGUARD SAFETY SYRINGE | Mar 8, 2000 | Substantially Equivalent |