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FDA 510(k)

FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE

K-Number: K872597 · 1987-07-28

ApplicantDianon Systems, Inc.
Decision Date1987-07-28
Product CodeDWO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE is the device name listed in this FDA 510(k) record. The listed applicant is Dianon Systems, Inc.. It received FDA 510(k) clearance on 1987-07-28 under 510(k) number K872597. 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 FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE?

FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE is a medical device that received FDA 510(k) clearance on 1987-07-28. The listed applicant is Dianon Systems, Inc.. The 510(k) number is K872597.

When did FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE receive FDA 510(k) clearance?

FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE received FDA 510(k) clearance on 1987-07-28, under 510(k) number K872597.

Who is the listed applicant for FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE?

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

What is the FDA product code for FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE?

The FDA product code for FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE 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 Dianon Systems, 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.

K882105CODE #D2020-FINE NEEDLE ASPIRATION BIOPSY SYSTEM

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.K885149NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICEHart Enterprises, 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.

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