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FDA 510(k)

SPINAL EPIDURAL NEEDLES

K-Number: K002405 · 2001-06-01

ApplicantTe ME NA S.A.R.L.
Decision Date2001-06-01
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPINAL EPIDURAL NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Te ME NA S.A.R.L.. It received FDA 510(k) clearance on 2001-06-01 under 510(k) number K002405. 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 SPINAL EPIDURAL NEEDLES?

SPINAL EPIDURAL NEEDLES is a medical device that received FDA 510(k) clearance on 2001-06-01. The listed applicant is Te ME NA S.A.R.L.. The 510(k) number is K002405.

When did SPINAL EPIDURAL NEEDLES receive FDA 510(k) clearance?

SPINAL EPIDURAL NEEDLES received FDA 510(k) clearance on 2001-06-01, under 510(k) number K002405.

Who is the listed applicant for SPINAL EPIDURAL NEEDLES?

The FDA 510(k) record lists Te ME NA S.A.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINAL EPIDURAL NEEDLES?

The FDA product code for SPINAL EPIDURAL NEEDLES is BSP.

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Other records listing Te ME NA S.A.R.L. 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.

K990323TE ME NA POLYSTIM NERVE STIMILATORK991259TE ME NA EPIDURAL CATHETERK990100POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLEK990020TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

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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