Cleared Special

K171348 - Pinpoint GT Needle Guide Kits

K171348 is an FDA 510(k) clearance for Pinpoint GT Needle Guide Kits, manufactured by C.R. Bard, Inc.. The device is a Class 2 Radiology device with product code ITX cleared through the Special 510(k) pathway after a 14-day FDA review.

K171348 · C.R. Bard, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
14d
Days
Class 2
Risk

K171348 is an FDA 510(k) clearance for the Pinpoint GT Needle Guide Kits. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 22, 2017 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K171348

510(k) Number K171348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2017
Decision Date May 22, 2017
Days to Decision 14 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 334
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K171348.
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range
K171040 · Koelis · Jul 2017
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
K163313 · CIVCO Medical Instruments Co., Inc. · Jun 2017
GTK Disposable Needle Guides
K170741 · Geotek Medikal Ltd Sti · Jun 2017
iSR'obot Biopsy Kit
K163502 · Biobot Surgical Pte., Ltd. · May 2017
A-View
K170338 · Stroke2prevent B.V. · May 2017
UST-5550-R
K152126 · Hitachi Aloka Medical America, Inc. · Aug 2016