RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles— 510(k) K203668

Substantially Equivalent

Myco Medical Supplies, Inc.

FDA 510(k) clearance K203668 for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles, Substantially Equivalent on 2021-09-29. Applicant: Myco Medical Supplies, Inc..

Clearance details

Applicant: Myco Medical Supplies, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2020-12-16
Decision date: 2021-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apex, NC, US

Download summary PDF View on FDA.gov ↗

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.