ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set— 510(k) K143164
Substantially EquivalentKimberly-Clark Corporation
FDA 510(k) clearance K143164 for ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set, Substantially Equivalent on 2014-12-02. Applicant: Kimberly-Clark Corporation. Device class: 2.
Clearance details
- Applicant
- Kimberly-Clark Corporation
- Product code
- Code BSO
- Device class
- Class 2
- Regulation
- 21 CFR 868.5120
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
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Adverse events under product code BSO
product code BSO- Malfunction
- 688
- Total
- 688
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.