Cleared Traditional

K170407 - BD ChloraShield IV Dressing with CHG Antimicrobial

K170407 · Avery Dennison Belgie Bvba · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2017
Decision
157d
Days
-
Risk

K170407 is an FDA 510(k) clearance for the BD ChloraShield IV Dressing with CHG Antimicrobial. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on July 17, 2017 after a review of 157 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Avery Dennison Belgie Bvba devices

FDA 510(k) Submission Details - K170407

510(k) Number K170407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2017
Decision Date July 17, 2017
Days to Decision 157 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 600
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