Cleared Traditional

K163437 - hypodermic Pinpoint™ GT Needle (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163437 · C.R. Bard, Inc. · General Hospital
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Jun 2017
Decision
198d
Days
Class 2
Risk

K163437 is an FDA 510(k) clearance for the hypodermic Pinpoint™ GT Needle. Classified as Non-stainless Steel Needle (product code PVZ), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on June 23, 2017 after a review of 198 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K163437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2016
Decision Date June 23, 2017
Days to Decision 198 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 128d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PVZ Non-stainless Steel Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition A Hypodermic Needle Is Intended To Inject Medication And Aspirate Fluid, Below The Surface Of The Skin. Designed To Be Used With Ultrasound For Better Visualization Of Needle During Use.
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 General Hospital devices follow this clearance model.