FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEEDLELOK HYPODERMIC NEEDLE PROTECTION
K Number: K011004
·
Decision May 24, 2001
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
10
Review Days
50
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Basic Information
- Device Name
- NEEDLELOK HYPODERMIC NEEDLE PROTECTION
- K Number
- K011004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diasol, Inc.
- Date Received
- April 4, 2001
- Decision Date
- May 24, 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 |
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Other Clearances by Diasol, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130511 | CITRISOL ACID CONCENTRATE | Feb 10, 2014 | Substantially Equivalent |
| K020231 | DIASOL-ADDITIVES | Oct 21, 2002 | Substantially Equivalent |
| K020230 | DIASOL-BICARB | Apr 23, 2002 | Substantially Equivalent |
| K010958 | FISTULOK FISTULA NEEDLE PROTECTION | May 18, 2001 | Substantially Equivalent |
| K011003 | SAFESTING AND SAFESTING HUB | Apr 20, 2001 | Substantially Equivalent |
| K993187 | SHELLY PROTECTED AV FISTULA NEEDLE | Nov 5, 1999 | Substantially Equivalent |
| K992999 | DAISY PROTECTED SCALP VEIN SET | Nov 5, 1999 | Substantially Equivalent |
| K992653 | SHELLY PROTECTED AV FISTULA NEEDLE | Oct 27, 1999 | Substantially Equivalent |
| K993212 | DRYASOL ACID CONCENTRATE MIX | Oct 22, 1999 | Substantially Equivalent |