FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTICARE DISPOSABLE PEN NEEDLES
K Number: K100812
·
Decision Jun 3, 2010
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
8
Review Days
72
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Basic Information
- Device Name
- ULTICARE DISPOSABLE PEN NEEDLES
- K Number
- K100812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultimed, Inc.
- Date Received
- March 23, 2010
- Decision Date
- June 3, 2010
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Ultimed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080600 | ULTIMED ULTICARE SAFETY SYRINGE | Jun 25, 2008 | Substantially Equivalent |
| K081449 | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER | Jun 3, 2008 | Substantially Equivalent |
| K062702 | ULTICARE DISPOSABLE SYRINGES AND NEEDLES | Nov 29, 2006 | Substantially Equivalent |
| K050464 | ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 | May 11, 2005 | Substantially Equivalent |
| K033794 | ULTICARE DISPOSABLE SYRINGE 3 ML/CC | Dec 30, 2003 | Substantially Equivalent |
| K021983 | ULTI GUARD HOME INSULIN SYRINGE CONTAINER | Sep 16, 2002 | Substantially Equivalent |
| K994230 | ULTICARE DISPOSABLE SYRINGE | Mar 24, 2000 | Substantially Equivalent |