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FDA 510(k)

BREAST LOCALIZATION NEEDLES

K-Number: K881730 · 1988-05-13

ApplicantHart Enterprises, Inc.
Decision Date1988-05-13
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BREAST LOCALIZATION NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Hart Enterprises, Inc.. It received FDA 510(k) clearance on 1988-05-13 under 510(k) number K881730. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAST LOCALIZATION NEEDLES?

BREAST LOCALIZATION NEEDLES is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Hart Enterprises, Inc.. The 510(k) number is K881730.

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

BREAST LOCALIZATION NEEDLES received FDA 510(k) clearance on 1988-05-13, under 510(k) number K881730.

Who is the listed applicant for BREAST LOCALIZATION NEEDLES?

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

What is the FDA product code for BREAST LOCALIZATION NEEDLES?

The FDA product code for BREAST LOCALIZATION NEEDLES is GDM.

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 Hart Enterprises, 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.

K921683PENCIL POINT SPINAL NEEDLEK913815AUTOMATED BIOPSY DEVICE, MODIFICATIONK885149NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE

Related Devices (Code: GDM)

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.

K071732MARROWMINERStemcor Systems, Inc.K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare CorpK953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.

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.

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