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FDA 510(k)

IMD's Lumbar Puncture Needle

K-Number: K170112 · 2018-02-02

ApplicantInternational Medical Development, Inc.(Imd)
Decision Date2018-02-02
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IMD's Lumbar Puncture Needle is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Development, Inc.(Imd). It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K170112. 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 IMD's Lumbar Puncture Needle?

IMD's Lumbar Puncture Needle is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is International Medical Development, Inc.(Imd). The 510(k) number is K170112.

When did IMD's Lumbar Puncture Needle receive FDA 510(k) clearance?

IMD's Lumbar Puncture Needle received FDA 510(k) clearance on 2018-02-02, under 510(k) number K170112.

Who is the listed applicant for IMD's Lumbar Puncture Needle?

The FDA 510(k) record lists International Medical Development, Inc.(Imd) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMD's Lumbar Puncture Needle?

The FDA product code for IMD's Lumbar Puncture Needle is BSP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02543983Neurobiology of SuicideRECRUITINGNCT06816979Lumbar Punctures for the Detection of ctDNA in the Cerebrospinal Fluid of Patients With Stage III and IV Non-Small Cell Lung CancerNOT_YET_RECRUITINGNCT07612644Hemorrhage Elimination During Lumbar Puncture Using Ultrasound Measurements (HELPUS)RECRUITING

Related Devices (Code: BSP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243690SonoMSKPAJUNK GmbH MedizintechnologieK243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH MedizintechnologieK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH MedizintechnologieK243525SonoTAP and SonoTAP IIPAJUNK GmbH MedizintechnologieK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH MedizintechnologieK241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie

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.

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