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: K944942 · 1994-11-04

ApplicantPromedical , Ltd.
Decision Date1994-11-04
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 Promedical , Ltd.. It received FDA 510(k) clearance on 1994-11-04 under 510(k) number K944942. 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 1994-11-04. The listed applicant is Promedical , Ltd.. The 510(k) number is K944942.

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

BREAST LESION LOCALIZATION NEEDLE received FDA 510(k) clearance on 1994-11-04, under 510(k) number K944942.

Who is the listed applicant for BREAST LESION LOCALIZATION NEEDLE?

The FDA 510(k) record lists Promedical , Ltd. 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 Promedical , Ltd. 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.

K954596PRO-B CORE-RECT COAXIAL BIOPSY SYSTEMK952350JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)K951598PRO-B BIOPSY NEEDLEK944944CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION 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.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, Inc.K935457LOCALIZATION WIRE OR MARKER - SURGICALBip USA, 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.

↑