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)

WESTERMAN-JENSEN BIOPSY NEEDLE

K-Number: K840168 · 1984-03-12

ApplicantPopper & Sons, Inc.
Decision Date1984-03-12
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WESTERMAN-JENSEN BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Popper & Sons, Inc.. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K840168. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WESTERMAN-JENSEN BIOPSY NEEDLE?

WESTERMAN-JENSEN BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Popper & Sons, Inc.. The 510(k) number is K840168.

When did WESTERMAN-JENSEN BIOPSY NEEDLE receive FDA 510(k) clearance?

WESTERMAN-JENSEN BIOPSY NEEDLE received FDA 510(k) clearance on 1984-03-12, under 510(k) number K840168.

Who is the listed applicant for WESTERMAN-JENSEN BIOPSY NEEDLE?

The FDA 510(k) record lists Popper & Sons, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WESTERMAN-JENSEN BIOPSY NEEDLE?

The FDA product code for WESTERMAN-JENSEN BIOPSY NEEDLE is FCG.

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 Popper & Sons, Inc. 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.

K911397HYPODERMIC NEEDLES, SINGLE LUMENK843830J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPIK843690ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLEK842406WESCOTT TYPE BIOPSY NEEDLEK841300ANTRUM NEEDLE-WOLF TYPEK841301GARDNER TYPE BONE MARROW NEEDLE

View all 8 devices →

Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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.

↑