Precision Point Biopsy Needle Guide

FDA 510(k) K160414 · Corbin Clinical Resources, LLC

Substantially Equivalent

510(k) numberK160414

Submission

Device name
Precision Point Biopsy Needle Guide
Applicant
Corbin Clinical Resources, LLC
Cumberland, MD, US
Received
February 16, 2016
Decision date
August 1, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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Questions and answers

When was Precision Point Biopsy Needle Guide cleared by the FDA?

Precision Point Biopsy Needle Guide (K160414) received a 510(k) decision of Substantially Equivalent on August 1, 2016, 167 days after the submission was received.

What is the product code of K160414?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.