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FDA 510(k)

PROACT BIOPSY NEEDLE ENCHANCEMENTS

K-Number: K926559 · 1993-03-22

ApplicantProact, Ltd.
Decision Date1993-03-22
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROACT BIOPSY NEEDLE ENCHANCEMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Proact, Ltd.. It received FDA 510(k) clearance on 1993-03-22 under 510(k) number K926559. 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 PROACT BIOPSY NEEDLE ENCHANCEMENTS?

PROACT BIOPSY NEEDLE ENCHANCEMENTS is a medical device that received FDA 510(k) clearance on 1993-03-22. The listed applicant is Proact, Ltd.. The 510(k) number is K926559.

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

PROACT BIOPSY NEEDLE ENCHANCEMENTS received FDA 510(k) clearance on 1993-03-22, under 510(k) number K926559.

Who is the listed applicant for PROACT BIOPSY NEEDLE ENCHANCEMENTS?

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

What is the FDA product code for PROACT BIOPSY NEEDLE ENCHANCEMENTS?

The FDA product code for PROACT BIOPSY NEEDLE ENCHANCEMENTS is FCG.

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Other records listing Proact, Ltd. 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.

K941256QUICK CORE IIK913306BONE-TEMNO/STERNUM-TEMNOK902320BAUER FLEXI-TEMNO BIOPSY NEEDLEK902319BAUER TEMNO 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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