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FDA 510(k)

TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE

K-Number: K073399 · 2007-12-21

ApplicantEnvisioneering, LLC
Decision Date2007-12-21
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Envisioneering, LLC. It received FDA 510(k) clearance on 2007-12-21 under 510(k) number K073399. 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 TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE?

TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE is a medical device that received FDA 510(k) clearance on 2007-12-21. The listed applicant is Envisioneering, LLC. The 510(k) number is K073399.

When did TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE receive FDA 510(k) clearance?

TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE received FDA 510(k) clearance on 2007-12-21, under 510(k) number K073399.

Who is the listed applicant for TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE?

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

What is the FDA product code for TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE?

The FDA product code for TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE 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 Envisioneering, LLC 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.

K041638TARGETSCAN BIOPSY KITK041639TARGETSCN TRANSRECTAL ULTRASOUND SYSTEMK041637TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM

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

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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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