FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K Number: K052117
·
Decision Sep 9, 2005
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
87
Applicant Total
41
Review Days
36
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Basic Information
- Device Name
- I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
- K Number
- K052117
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- I-Flow Corp.
- Date Received
- August 4, 2005
- Decision Date
- September 9, 2005
- Product Code
- MEB
- 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 |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | FDA class 2 | General Hospital |
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ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
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Other Clearances by I-Flow Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K063530 | ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP | Jan 26, 2007 | Substantially Equivalent |
| K063234 | ON-Q INTRODUCERS | Nov 21, 2006 | Substantially Equivalent |
| K051401 | ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER | Nov 30, 2005 | Substantially Equivalent |
| K043456 | MODIFICATION TO SOAKER CATHETER | Jan 11, 2005 | Substantially Equivalent |
| K040337 | I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) | May 24, 2004 | Substantially Equivalent |
| K023883 | HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO | Dec 20, 2002 | Substantially Equivalent |
| K023827 | PARAGON INFUSION SYSTEM WITH BOLUS | Dec 13, 2002 | Substantially Equivalent |
| K023318 | I-FLOW ELASTOMERIC PUMP WITH BOLUS | Oct 18, 2002 | Substantially Equivalent |
| K022869 | SOAKER CATHETER | Sep 20, 2002 | Substantially Equivalent |
| K020862 | I-FLOW ELASTOMERIC PUMP | Mar 26, 2002 | Substantially Equivalent |