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FDA 510(k)

SPINAL NEEDLES

K-Number: K961151 · 1997-03-19

ApplicantHakko Shoji Co., Ltd.
Decision Date1997-03-19
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPINAL NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Hakko Shoji Co., Ltd.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K961151. 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 NEEDLES?

SPINAL NEEDLES is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Hakko Shoji Co., Ltd.. The 510(k) number is K961151.

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

SPINAL NEEDLES received FDA 510(k) clearance on 1997-03-19, under 510(k) number K961151.

Who is the listed applicant for SPINAL NEEDLES?

The FDA 510(k) record lists Hakko Shoji Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPINAL NEEDLES?

The FDA product code for SPINAL NEEDLES is BSP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hakko Shoji Co., Ltd. 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.

K020307LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112K961152TUOHY EPIDURAL NEEDLES

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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