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FDA 510(k)

SECURCUT ASPIRATION BIOPSY NEEDLE

K-Number: K013071 · 2001-12-12

ApplicantH.S. Hospital Services S.P.A.
Decision Date2001-12-12
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SECURCUT ASPIRATION BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is H.S. Hospital Services S.P.A.. It received FDA 510(k) clearance on 2001-12-12 under 510(k) number K013071. 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 SECURCUT ASPIRATION BIOPSY NEEDLE?

SECURCUT ASPIRATION BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 2001-12-12. The listed applicant is H.S. Hospital Services S.P.A.. The 510(k) number is K013071.

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

SECURCUT ASPIRATION BIOPSY NEEDLE received FDA 510(k) clearance on 2001-12-12, under 510(k) number K013071.

Who is the listed applicant for SECURCUT ASPIRATION BIOPSY NEEDLE?

The FDA 510(k) record lists H.S. Hospital Services S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECURCUT ASPIRATION BIOPSY NEEDLE?

The FDA product code for SECURCUT ASPIRATION 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.

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Other records listing H.S. Hospital Services S.P.A. 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.

K013070JAMSHIDI BIOPSY NEEDLEK013069BIOSPEED

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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