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)

PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM

K-Number: K080674 · 2008-05-09

ApplicantPAJUNK GmbH Medizintechnologie
Decision Date2008-05-09
Product CodeMJG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is PAJUNK GmbH Medizintechnologie. It received FDA 510(k) clearance on 2008-05-09 under 510(k) number K080674. The device is classified under product code MJG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM?

PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is PAJUNK GmbH Medizintechnologie. The 510(k) number is K080674.

When did PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM receive FDA 510(k) clearance?

PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM received FDA 510(k) clearance on 2008-05-09, under 510(k) number K080674.

Who is the listed applicant for PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM?

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

What is the FDA product code for PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM?

The FDA product code for PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM is MJG.

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 Medizintechnologie 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.

K243690SonoMSKK243682SonoPlex STIM; SonoPlex IIK250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PunctureK243525SonoTAP and SonoTAP IIK241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyK241954SonoBlock; SonoBlock II

View all 44 devices →

Related Devices (Code: MJG)

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.

K070836EXICLIP EXCS-MClevex, Inc.K983647ECHO-COAT ULTRASOUND NEEDLESSts BiopolymersK955683RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAYContour Fabricators of Florida, Inc.K933324SKIN BIOPSY DEVICENhr, Inc.K925870SPACERBip USA, Inc.K922919DYNACYT BIOPSY ASPIRATION DEVICEBuckman Co., Inc.

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.

↑