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FDA 510(k)

SILENT BIOPSY NEEDLE

K-Number: K002946 · 2000-12-19

ApplicantH.S. Hospital Service S.R.L.
Decision Date2000-12-19
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SILENT BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is H.S. Hospital Service S.R.L.. It received FDA 510(k) clearance on 2000-12-19 under 510(k) number K002946. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILENT BIOPSY NEEDLE?

SILENT BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 2000-12-19. The listed applicant is H.S. Hospital Service S.R.L.. The 510(k) number is K002946.

When did SILENT BIOPSY NEEDLE receive FDA 510(k) clearance?

SILENT BIOPSY NEEDLE received FDA 510(k) clearance on 2000-12-19, under 510(k) number K002946.

Who is the listed applicant for SILENT BIOPSY NEEDLE?

The FDA 510(k) record lists H.S. Hospital Service S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILENT BIOPSY NEEDLE?

The FDA product code for SILENT BIOPSY NEEDLE is FCG.

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 H.S. Hospital Service S.R.L. 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.

K021525TOPCUTK020987BMN I TYPE MARROW ASPIRATION NEEDLEK013692TRAPSYSTEM SETK002947BIOMOL ASPIRATION BIOPSY NEEDLEK002944PRECISA BIOPSY NEEDLE

Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, Ltd.

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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