Cleared Special

K182680 - KerraContact Ag Perf Advanced Perforate...

K182680 · Exciton Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
71d
Days
-
Risk

K182680 is an FDA 510(k) clearance for the KerraContact Ag Perf Advanced Perforated Silver Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Exciton Technologies, Inc. (Edmonton, CA). The FDA issued a Cleared decision on December 6, 2018 after a review of 71 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.

View all Exciton Technologies, Inc. devices

Submission Details

510(k) Number K182680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2018
Decision Date December 06, 2018
Days to Decision 71 days
Submission Type Special
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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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