Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles

K-Number: K203668 · 2021-09-29

ApplicantMyco Medical Supplies, Inc.
Decision Date2021-09-29
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles is a medical device manufactured by Myco Medical Supplies, Inc.. It received FDA 510(k) clearance on 2021-09-29 under approval number K203668. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles is a medical device that received FDA 510(k) clearance on 2021-09-29. It is manufactured by Myco Medical Supplies, Inc.. The 510(k) number is K203668.

When was RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles approved by the FDA?

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles received FDA 510(k) clearance on 2021-09-29, under approval number K203668.

What company makes RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles is manufactured by Myco Medical Supplies, Inc..

What is the FDA product code for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles?

The FDA product code for RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles is BSP.

Related Clinical Trials

NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT07579611 Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy NOT_YET_RECRUITING NCT07569783 tDCS for Reducing the Incidence of OEI After Cesarean Section NOT_YET_RECRUITING NCT04193709 Recovery of Bladder and Sexual Function After Human Spinal Cord Injury COMPLETED NCT06281249 Neuraxial Ultrasound Device Study NOT_YET_RECRUITING NCT05665998 Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation RECRUITING

Other Devices by Myco Medical Supplies, Inc.

K173279RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder

Related Devices (Code: BSP)

K160297Tuohy NRFitPAJUNK GmbH Medizintechnologie K160295SPROTTE NRFit, Quincke NRFitPAJUNK GmbH Medizintechnologie K160296SPROTTE SPECIAL NRFitPAJUNK GmbH Medizintechnologie K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesPAJUNK GmbH Medizintechnologie K151069SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction NeedleSpectra Medical Devices, Inc. K151072Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle KitSolo-Dex, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑