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FDA 510(k)

FLEXIBLE SPINAL NEEDLE

K-Number: K043467 · 2005-03-31

ApplicantEpimed International, Inc.
Decision Date2005-03-31
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE SPINAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Epimed International, Inc.. It received FDA 510(k) clearance on 2005-03-31 under 510(k) number K043467. 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 FLEXIBLE SPINAL NEEDLE?

FLEXIBLE SPINAL NEEDLE is a medical device that received FDA 510(k) clearance on 2005-03-31. The listed applicant is Epimed International, Inc.. The 510(k) number is K043467.

When did FLEXIBLE SPINAL NEEDLE receive FDA 510(k) clearance?

FLEXIBLE SPINAL NEEDLE received FDA 510(k) clearance on 2005-03-31, under 510(k) number K043467.

Who is the listed applicant for FLEXIBLE SPINAL NEEDLE?

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

What is the FDA product code for FLEXIBLE SPINAL NEEDLE?

The FDA product code for FLEXIBLE SPINAL NEEDLE is BSP.

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Other records listing Epimed International, Inc. 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.

K200624Percutaneous IntroducerK190256Rulo Radiofrequency Lesion ProbeK053318RX EPIDURAL NEEDLEK051171STINGRAY EPIDURAL CATHETER CONNECTORK051860FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837K041021RF INTRODUCTION CANNULA

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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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