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FDA 510(k)

EPIDURAL NEEDLE

K-Number: K942863 · 1995-08-11

ApplicantSpinal Specialties, Inc.
Decision Date1995-08-11
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EPIDURAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Specialties, Inc.. It received FDA 510(k) clearance on 1995-08-11 under 510(k) number K942863. 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 EPIDURAL NEEDLE?

EPIDURAL NEEDLE is a medical device that received FDA 510(k) clearance on 1995-08-11. The listed applicant is Spinal Specialties, Inc.. The 510(k) number is K942863.

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

EPIDURAL NEEDLE received FDA 510(k) clearance on 1995-08-11, under 510(k) number K942863.

Who is the listed applicant for EPIDURAL NEEDLE?

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

What is the FDA product code for EPIDURAL NEEDLE?

The FDA product code for EPIDURAL NEEDLE is BSP.

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Other records listing Spinal Specialties, 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.

K960100SPINAL SPECIALTIES NERVE BLOCK TRAYK960082DISCOGRAPHY KITK950820SPINAL SPECIALTIES PENCIL-POINT SPINAL NEEDLEK943319GERTIE MARX EPI-SPINAL TRAYK944029CONTINUOUS EPIDURAL ANESTHESIA TRAYK941343SPINAL ANESTHESIA TRAY

View all 8 devices →

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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