Cleared Traditional

K163216 - Pinpoint GT Needles

K163216 is an FDA 510(k) clearance for Pinpoint GT Needles, manufactured by C.R. Bard, Inc.. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K163216 · C.R. Bard, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
223d
Days
Class 2
Risk

K163216 is an FDA 510(k) clearance for the Pinpoint GT Needles. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on June 27, 2017 after a review of 223 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K163216

510(k) Number K163216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2016
Decision Date June 27, 2017
Days to Decision 223 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 140d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 72
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K163216.
EchoGlo Needle
K171968 · Smiths Medical Asd, Inc. · Jan 2018
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
K171518 · Zhejiang Kindly Medical Devices Co., Ltd. · Jan 2018
NerveGuard NRFit, NerveGuard LUER
K170435 · PAJUNK GmbH Medizintechnologie · Jul 2017
Entellus Medical Reinforced Anesthesia Needle
K163435 · Entellus Medical, Inc. · Apr 2017
Tuohy NRFit
K160297 · PAJUNK GmbH Medizintechnologie · Oct 2016
SPROTTE NRFit, Quincke NRFit
K160295 · PAJUNK GmbH Medizintechnologie · Oct 2016