ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
FDA 510(k) clearance K131249 · decided 2014-02-03
Clearance details
- K-number
- K131249
- Device name
- ON-Q PAINBUSTER, ON-Q C-BLOC, HOMEPUMP ECLIPSE, HOMEPUMP C-SERIES
- Applicant
- I-Flow, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-05-01
- Decision date
- 2014-02-03
- Days to decision
- 278 days
- Clearance type
- Traditional
- Product code
- MEB
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.