Cleared Special

K171908 - 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (FDA 510(k) Clearance)

K171908 · 3M Company · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2017
Decision
15d
Days
-
Risk

K171908 is an FDA 510(k) clearance for the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing. Classified as Securement Wound Dressing For Reduction Of Infection (product code SEL).

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on July 11, 2017 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

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Submission Details

510(k) Number K171908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2017
Decision Date July 11, 2017
Days to Decision 15 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 114d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code SEL Securement Wound Dressing For Reduction Of Infection
Device Class -
Definition These Dressings Are Intended To Be Placed Over A Vascular Or Percutaneous Device (e.g., Needle, Catheter, Drain) To Keep It Securely Anchored To The Skin, Cover And Protect The Insertion Site, And May Additionally Absorb Exudate. When Used To Secure Central Venous Or Arterial Catheters, A Securement Wound Dressing For Reduction Of Infection Is Intended To Reduce Microbial Colonization Around The Insertion Site And Reduce The Incidence Of Catheter-related Bloodstream Infections (crbsi).