ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP— 510(k) K063530
Substantially EquivalentI-Flow Corp.
FDA 510(k) clearance K063530 for ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP, Substantially Equivalent on 2007-01-26. Applicant: I-Flow Corp.. Device class: 2.
Clearance details
- Applicant
- I-Flow Corp.
- Product code
- Code MEB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lake Forest, CA, US
Recent devices under product code MEB
view allMore clearances from I-Flow Corp.
view all- K063234 — ON-Q INTRODUCERS
- K051401 — ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER
- K052117 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
- K043456 — MODIFICATION TO SOAKER CATHETER
- K040337 — I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
Adverse events under product code MEB
product code MEB- Death
- 6
- Injury
- 160
- Malfunction
- 10,053
- Other
- 5
- Total
- 10,224
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.