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FDA 510(k)

LAURUS NEEDLE CORE BIOPSY SYSTEM

K-Number: K960317 · 1996-03-15

ApplicantLaurus Medical Corp.
Decision Date1996-03-15
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAURUS NEEDLE CORE BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laurus Medical Corp.. It received FDA 510(k) clearance on 1996-03-15 under 510(k) number K960317. 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 LAURUS NEEDLE CORE BIOPSY SYSTEM?

LAURUS NEEDLE CORE BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-15. The listed applicant is Laurus Medical Corp.. The 510(k) number is K960317.

When did LAURUS NEEDLE CORE BIOPSY SYSTEM receive FDA 510(k) clearance?

LAURUS NEEDLE CORE BIOPSY SYSTEM received FDA 510(k) clearance on 1996-03-15, under 510(k) number K960317.

Who is the listed applicant for LAURUS NEEDLE CORE BIOPSY SYSTEM?

The FDA 510(k) record lists Laurus Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAURUS NEEDLE CORE BIOPSY SYSTEM?

The FDA product code for LAURUS NEEDLE CORE BIOPSY SYSTEM 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 Laurus Medical Corp. 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.

K973415CURVILINEAR SUTURE PLACEMENT SYSTEMK973215STEREOTACTIC NEEDLE CORE BIOPSY SYSTEMK932553DISPOSABLE SUTURE PLACEMENT 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

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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