Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters— 510(k) K172410

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K172410 for Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters, Substantially Equivalent on 2018-06-01. Applicant: Smiths Medical Asd, Inc..

Clearance details

Applicant: Smiths Medical Asd, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2017-08-09
Decision date: 2018-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.