Cleared Special

High Performance Antimicrobial Gelling Fiber with Silver (K210974) - FDA 510(k) Clearance

K210974 · Advanced Medical Solutions, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
41d
Days
-
Risk

K210974 is an FDA 510(k) clearance for the High Performance Antimicrobial Gelling Fiber with Silver. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Advanced Medical Solutions, Ltd. (Winsford, GB). The FDA issued a Cleared decision on May 12, 2021 after a review of 41 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 Advanced Medical Solutions, Ltd. devices

Submission Details

510(k) Number K210974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2021
Decision Date May 12, 2021
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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