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510(k) K203668

Device
RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
Applicant
MYCO Medical Supplies, Inc.
510(k) number
K203668
Product code
BSP  
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-29
Date received
2020-12-16
Regulation
868.5150
Classification name
Needle, Conduction, Anesthetic (w/wo Introducer)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sanjiv Krumar
Address
2015 Production Dr. Apex NC US 27539 27539

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BSP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243690SonoMSKPAJUNK GmbH Medizintechnologie2025-07-01
K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie2025-06-27
K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH Medizintechnologie2025-06-25
K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie2025-03-24
K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie2024-11-22
K241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie2024-09-11
K240253Reach NeedleAerin Medical, Inc.2024-03-21
K212982Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited2022-07-29
K211085BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural NeedleBecton, Dickinson and Company2022-07-01
K210978BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer NeedleBecton, Dickinson and Company2021-12-22
K212328DiscCath Needle SetDisccath, LLC2021-09-26
K193131BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit NeedleBecton, Dickinson and Company2020-09-29
K192914Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V.2020-05-27
K191290Ancora Nerve Block Catheter SetAncora Medical Technology2020-02-06
K190026Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)Teleflex Medical2019-08-21

Legacy Summary#

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FDA Review#

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