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FDA 510(k)

PINPOINT NEEDLE

K-Number: K853478 · 1986-01-15

ApplicantRegional Master Corp.
Decision Date1986-01-15
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PINPOINT NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Regional Master Corp.. It received FDA 510(k) clearance on 1986-01-15 under 510(k) number K853478. 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 PINPOINT NEEDLE?

PINPOINT NEEDLE is a medical device that received FDA 510(k) clearance on 1986-01-15. The listed applicant is Regional Master Corp.. The 510(k) number is K853478.

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

PINPOINT NEEDLE received FDA 510(k) clearance on 1986-01-15, under 510(k) number K853478.

Who is the listed applicant for PINPOINT NEEDLE?

The FDA 510(k) record lists Regional Master Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PINPOINT NEEDLE?

The FDA product code for PINPOINT NEEDLE 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 Regional Master Corp. 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.

K853422THE GRIPPERK853476T4 MONITOR STIMULATOR COMPUTERK853477NERVE FINDER

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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