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)

Dr J Spinal and Epidural Needles

K-Number: K183316 · 2019-08-12

ApplicantDr. Japan Co., Ltd.
Decision Date2019-08-12
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Dr J Spinal and Epidural Needles is a medical device manufactured by Dr. Japan Co., Ltd.. It received FDA 510(k) clearance on 2019-08-12 under approval number K183316. 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 Dr J Spinal and Epidural Needles?

Dr J Spinal and Epidural Needles is a medical device that received FDA 510(k) clearance on 2019-08-12. It is manufactured by Dr. Japan Co., Ltd.. The 510(k) number is K183316.

When was Dr J Spinal and Epidural Needles approved by the FDA?

Dr J Spinal and Epidural Needles received FDA 510(k) clearance on 2019-08-12, under approval number K183316.

What company makes Dr J Spinal and Epidural Needles?

Dr J Spinal and Epidural Needles is manufactured by Dr. Japan Co., Ltd..

What is the FDA product code for Dr J Spinal and Epidural Needles?

The FDA product code for Dr J Spinal and Epidural 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

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.

↑