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FDA 510(k)

DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)

K-Number: K951928 · 1997-05-30

ApplicantCsen , Ltd.
Decision Date1997-05-30
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) is the device name listed in this FDA 510(k) record. The listed applicant is Csen , Ltd.. It received FDA 510(k) clearance on 1997-05-30 under 510(k) number K951928. 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 DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)?

DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) is a medical device that received FDA 510(k) clearance on 1997-05-30. The listed applicant is Csen , Ltd.. The 510(k) number is K951928.

When did DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) receive FDA 510(k) clearance?

DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) received FDA 510(k) clearance on 1997-05-30, under 510(k) number K951928.

Who is the listed applicant for DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)?

The FDA 510(k) record lists Csen , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)?

The FDA product code for DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Csen , Ltd. as applicant

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.

K951927COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)K935255ELDOR NEEDLE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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