ON-Q* Pump with Bolus— 510(k) K181360
Substantially EquivalentHalyard Health
FDA 510(k) clearance K181360 for ON-Q* Pump with Bolus, Substantially Equivalent on 2019-03-22. Applicant: Halyard Health. Device class: 2.
Clearance details
- Applicant
- Halyard Health
- 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
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code MEB
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- K160709 — HALYARD* PURPLE NITRILE XTRA* Powder-Free Exam Gloves
- K153708 — Halyard Black-Orange Powder-Free Nitrile Exam Glove
- K150113 — Fusion Black Powder-Free Nitrile Exam Glove
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.