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)

BREAST LESION LOCALIZATION NEEDLE

K-Number: K924270 · 1992-09-23

ApplicantCore Medical, Inc.
Decision Date1992-09-23
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BREAST LESION LOCALIZATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Core Medical, Inc.. It received FDA 510(k) clearance on 1992-09-23 under 510(k) number K924270. The device is classified under product code GDF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAST LESION LOCALIZATION NEEDLE?

BREAST LESION LOCALIZATION NEEDLE is a medical device that received FDA 510(k) clearance on 1992-09-23. The listed applicant is Core Medical, Inc.. The 510(k) number is K924270.

When did BREAST LESION LOCALIZATION NEEDLE receive FDA 510(k) clearance?

BREAST LESION LOCALIZATION NEEDLE received FDA 510(k) clearance on 1992-09-23, under 510(k) number K924270.

Who is the listed applicant for BREAST LESION LOCALIZATION NEEDLE?

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

What is the FDA product code for BREAST LESION LOCALIZATION NEEDLE?

The FDA product code for BREAST LESION LOCALIZATION NEEDLE is GDF.

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 Core Medical, 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.

K924271CHIBA/FRANSEEN/WESTCOTT/SPINAL STYLE NEEDLESK914732CORE MEDICAL BIOPSY NEEDLE

Related Devices (Code: GDF)

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.

K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco HealthcK945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, 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.

↑