Cleared Special

Sherlock 3CG Tip Positioning System Stylet (K172397) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172397 · C.R. Bard, Inc. · General Hospital
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Sep 2017
Decision
52d
Days
Class 2
Risk

K172397 is an FDA 510(k) clearance for the Sherlock 3CG Tip Positioning System Stylet. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on September 29, 2017 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device 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

Submission Details

510(k) Number K172397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2017
Decision Date September 29, 2017
Days to Decision 52 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 129d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 95
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K172397.
Vygon PICCs
K172899 · Vygon USA · Feb 2018
Silicone Peripherally Inserted Central Venous Catheter Set/Tray
K171994 · Cook Incorporated · Feb 2018
HydroPICC
K172885 · Access Vascular, Inc. · Feb 2018
PowerPICC Provena Catheters with SOLO Valve Technology
K162441 · C.R. Bard, Inc. · Apr 2017
PowerPICC Provena Catheters
K162443 · C.R. Bard, Inc. · Oct 2016
Turbo-Flo PICC Sets
K161496 · Cook Incorporated · Oct 2016