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)

Medispine - Spinal Needle, Glospine - Spinal Needle

K-Number: K212982 · 2022-07-29

ApplicantGlobal Medikit Limited
Decision Date2022-07-29
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Medispine - Spinal Needle, Glospine - Spinal Needle is a medical device manufactured by Global Medikit Limited. It received FDA 510(k) clearance on 2022-07-29 under approval number K212982. 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 Medispine - Spinal Needle, Glospine - Spinal Needle?

Medispine - Spinal Needle, Glospine - Spinal Needle is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Global Medikit Limited. The 510(k) number is K212982.

When was Medispine - Spinal Needle, Glospine - Spinal Needle approved by the FDA?

Medispine - Spinal Needle, Glospine - Spinal Needle received FDA 510(k) clearance on 2022-07-29, under approval number K212982.

What company makes Medispine - Spinal Needle, Glospine - Spinal Needle?

Medispine - Spinal Needle, Glospine - Spinal Needle is manufactured by Global Medikit Limited.

What is the FDA product code for Medispine - Spinal Needle, Glospine - Spinal Needle?

The FDA product code for Medispine - Spinal Needle, Glospine - Spinal Needle is BSP.

Related Clinical Trials

NCT06281249 Neuraxial Ultrasound Device Study NOT_YET_RECRUITING NCT06816979 Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung Cancer NOT_YET_RECRUITING

Other Devices by Global Medikit Limited

K193158ACENT™ Central Venous Catheter

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.

↑