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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 a medical device manufactured by Corbin Clinical Resources, LLC. It received FDA 510(k) clearance on 2016-09-02 under approval 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. It is manufactured by Corbin Clinical Resources, LLC. The 510(k) number is K160423.

When was Perineologic Access Needle approved by the FDA?

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

What company makes Perineologic Access Needle?

Perineologic Access Needle is manufactured by Corbin Clinical Resources, LLC.

What is the FDA product code for Perineologic Access Needle?

The FDA product code for Perineologic Access Needle is FCG.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING

Other Devices by Corbin Clinical Resources, LLC

K160414Precision Point Biopsy Needle Guide

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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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