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510(k) K854816

Device
EPIDURAL ANESTHESIA NEEDLES
Applicant
REGANES, INC.
510(k) number
K854816
Product code
BSP  
Decision
Substantially Equivalent (SESE)
Decision date
1985-12-19
Date received
1985-12-03
Regulation
868.5150
Classification name
Needle, Conduction, Anesthetic (w/wo Introducer)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOSEPH E HARMS
Address
P.O. Box 13212 Clearwater FL US 33519 33519

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K203668RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal NeedlesMyco Medical Supplies, Inc.2021-09-29
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

Legacy Summary#

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FDA Review#

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