Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UNIPOLAR NEEDLES

K-Number: K000722 · 2000-03-31

ApplicantPajunk GmbH
Decision Date2000-03-31
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNIPOLAR NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Pajunk GmbH. It received FDA 510(k) clearance on 2000-03-31 under 510(k) number K000722. 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 UNIPOLAR NEEDLES?

UNIPOLAR NEEDLES is a medical device that received FDA 510(k) clearance on 2000-03-31. The listed applicant is Pajunk GmbH. The 510(k) number is K000722.

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

UNIPOLAR NEEDLES received FDA 510(k) clearance on 2000-03-31, under 510(k) number K000722.

Who is the listed applicant for UNIPOLAR NEEDLES?

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

What is the FDA product code for UNIPOLAR NEEDLES?

The FDA product code for UNIPOLAR 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 Pajunk GmbH 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.

K113207SONO TAP, TUOHY SONOK113209CHIBA SONOK060563EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IVK053283UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SETK053282ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIPK043130MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS

View all 19 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.

↑