Cleared Traditional

K180643 - MedCu Antibacterial Wound Dressings wit...

K180643 · Medcu Technologies , Ltd. · General & Plastic Surgery device
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Nov 2018
Decision
256d
Days
-
Risk

K180643 is an FDA 510(k) clearance for the MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medcu Technologies , Ltd. (Herzlia, IL). The FDA issued a Cleared decision on November 23, 2018 after a review of 256 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 Medcu Technologies , Ltd. devices

Submission Details

510(k) Number K180643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2018
Decision Date November 23, 2018
Days to Decision 256 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
141d slower than avg
Panel avg: 115d · This submission: 256d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Talmed , Ltd.
Tali Hazan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRO Dressing, Wound, Drug

All 211
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BIAFINE
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