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FDA 510(k)

NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE

K-Number: K885149 · 1989-01-26

ApplicantHart Enterprises, Inc.
Decision Date1989-01-26
Product CodeDWO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE 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 1989-01-26 under 510(k) number K885149. The device is classified under product code DWO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE?

NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 1989-01-26. The listed applicant is Hart Enterprises, Inc.. The 510(k) number is K885149.

When did NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE receive FDA 510(k) clearance?

NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE received FDA 510(k) clearance on 1989-01-26, under 510(k) number K885149.

Who is the listed applicant for NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE?

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 NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE?

The FDA product code for NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE is DWO.

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, MODIFICATIONK881730BREAST LOCALIZATION NEEDLES

Related Devices (Code: DWO)

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.

K933364PROMED BIOPSY NEEDLEVlv Associates, Inc.K921418ULTRA-CORE BIOPSY NEEDLESMedical Device Technologies, Inc.K913815AUTOMATED BIOPSY DEVICE, MODIFICATIONHart Enterprises, Inc.K890925MANAN BONE MARROW BIOPSY NEEDLEManan Medical Products, Inc.K885145MEDSURG GREENE NEEDLEMedsurg Industries, Inc.K882013SOFT TISSUE BIOPSY DEVICEOcean Medical Products, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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