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FDA 510(k)

BIOSPEED

K-Number: K013069 · 2001-12-12

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

Device Summary

BIOSPEED 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 K013069. 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 BIOSPEED?

BIOSPEED 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 K013069.

When did BIOSPEED receive FDA 510(k) clearance?

BIOSPEED received FDA 510(k) clearance on 2001-12-12, under 510(k) number K013069.

Who is the listed applicant for BIOSPEED?

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 BIOSPEED?

The FDA product code for BIOSPEED 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.

K013071SECURCUT ASPIRATION BIOPSY NEEDLEK013070JAMSHIDI 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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