FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHIELDING NEEDLE HOLDER
K Number: K003381
·
Decision Apr 23, 2001
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
7
Review Days
174
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SHIELDING NEEDLE HOLDER
- K Number
- K003381
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- U.S. Safety Syringes Co., Inc.
- Date Received
- October 31, 2000
- Decision Date
- April 23, 2001
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMI), ordered by most recent decision date.
Profoject Safety Pen Needles
FDA 510(k)
FDA Class 2
·General Hospital
Verisafe Safety Sterile Needles (SSN)
FDA 510(k)
FDA Class 2
·General Hospital
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
PRESSONE
FDA 510(k)
FDA Class 2
·General Hospital
Safety Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
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 |
| K090122 | NUOVOGUARD | Feb 5, 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 |
| K990831 | SUPERGUARD SAFETY SYRINGE | Mar 8, 2000 | Substantially Equivalent |