Portex NRFit Epidural Needles— 510(k) K172823
Substantially EquivalentSmiths Medical Asd, Inc.
FDA 510(k) clearance K172823 for Portex NRFit Epidural Needles, Substantially Equivalent on 2018-06-12. Applicant: Smiths Medical Asd, Inc.. Device class: 2.
Clearance details
- Applicant
- Smiths Medical Asd, Inc.
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code BSP
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Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
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.