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FDA 510(k)

SPINAL NEEDLE

K-Number: K895453 · 1989-10-19

ApplicantAdvance Medical Designs, Inc.
Decision Date1989-10-19
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPINAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 1989-10-19 under 510(k) number K895453. 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 NEEDLE?

SPINAL NEEDLE is a medical device that received FDA 510(k) clearance on 1989-10-19. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K895453.

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

SPINAL NEEDLE received FDA 510(k) clearance on 1989-10-19, under 510(k) number K895453.

Who is the listed applicant for SPINAL NEEDLE?

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

What is the FDA product code for SPINAL NEEDLE?

The FDA product code for SPINAL NEEDLE is BSP.

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Other records listing Advance Medical Designs, 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.

K223689Disposable Needle Guides and GridsK163050Advance Medical Designs, Inc. Sterile Ultrasound GelK053495EQUIPMENT SLUSH DRAPEK011265ULTRASOUND TRANSDUCER COVERK012168ADVANCE MEDICAL DESIGNS FLUID POUCHK011422SURGICAL DRAPES

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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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