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FDA 510(k)

Perineologic Access Needle

K-Number: K160423 · 2016-09-02

ApplicantCorbin Clinical Resources, LLC
Decision Date2016-09-02
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Perineologic Access Needle is the device name listed in this FDA 510(k) record. The listed applicant is Corbin Clinical Resources, LLC. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K160423. 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 Perineologic Access Needle?

Perineologic Access Needle is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Corbin Clinical Resources, LLC. The 510(k) number is K160423.

When did Perineologic Access Needle receive FDA 510(k) clearance?

Perineologic Access Needle received FDA 510(k) clearance on 2016-09-02, under 510(k) number K160423.

Who is the listed applicant for Perineologic Access Needle?

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

What is the FDA product code for Perineologic Access Needle?

The FDA product code for Perineologic Access Needle is FCG.

Other records listing Corbin Clinical Resources, 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.

K160414Precision Point Biopsy Needle Guide

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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