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FDA 510(k)

ELDOR NEEDLE

K-Number: K935255 · 1995-02-01

ApplicantCsen , Ltd.
Decision Date1995-02-01
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ELDOR 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 1995-02-01 under 510(k) number K935255. 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 ELDOR NEEDLE?

ELDOR NEEDLE is a medical device that received FDA 510(k) clearance on 1995-02-01. The listed applicant is Csen , Ltd.. The 510(k) number is K935255.

When did ELDOR NEEDLE receive FDA 510(k) clearance?

ELDOR NEEDLE received FDA 510(k) clearance on 1995-02-01, under 510(k) number K935255.

Who is the listed applicant for ELDOR 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 ELDOR NEEDLE?

The FDA product code for ELDOR NEEDLE is BSP.

Related Clinical Trials

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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.

K951928DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)K951927COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)

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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