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FDA 510(k)

Dr J Spinal and Epidural Needles

K-Number: K183316 · 2019-08-12

ApplicantDr. Japan Co., Ltd.
Decision Date2019-08-12
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Dr J Spinal and Epidural Needles is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Japan Co., Ltd.. It received FDA 510(k) clearance on 2019-08-12 under 510(k) number K183316. 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 Dr J Spinal and Epidural Needles?

Dr J Spinal and Epidural Needles is a medical device that received FDA 510(k) clearance on 2019-08-12. The listed applicant is Dr. Japan Co., Ltd.. The 510(k) number is K183316.

When did Dr J Spinal and Epidural Needles receive FDA 510(k) clearance?

Dr J Spinal and Epidural Needles received FDA 510(k) clearance on 2019-08-12, under 510(k) number K183316.

Who is the listed applicant for Dr J Spinal and Epidural Needles?

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

What is the FDA product code for Dr J Spinal and Epidural Needles?

The FDA product code for Dr J Spinal and Epidural Needles is BSP.

Related Clinical Trials

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NCT07654907Clinical Evaluation of the EpiFaith™ Syringe in Epidural Pain ManagementNOT_YET_RECRUITINGNCT07708909Two Different Sized Spinal Needles DPE vs Conventional Epidural TechniqueNOT_YET_RECRUITING

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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