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FDA 510(k)

TUOHY EPIDURAL NEEDLE

K-Number: K030562 · 2003-04-03

ApplicantEpimed International, Inc.
Decision Date2003-04-03
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TUOHY EPIDURAL 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 2003-04-03 under 510(k) number K030562. 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 TUOHY EPIDURAL NEEDLE?

TUOHY EPIDURAL NEEDLE is a medical device that received FDA 510(k) clearance on 2003-04-03. The listed applicant is Epimed International, Inc.. The 510(k) number is K030562.

When did TUOHY EPIDURAL NEEDLE receive FDA 510(k) clearance?

TUOHY EPIDURAL NEEDLE received FDA 510(k) clearance on 2003-04-03, under 510(k) number K030562.

Who is the listed applicant for TUOHY EPIDURAL 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 TUOHY EPIDURAL NEEDLE?

The FDA product code for TUOHY EPIDURAL 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.

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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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