Cleared Traditional

ALGS6 Ag Alginate Wound Dressing (K172570) - FDA 510(k) Clearance

K172570 · Foshan United Medical Technologies, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2018
Decision
256d
Days
-
Risk

K172570 is an FDA 510(k) clearance for the ALGS6 Ag Alginate Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Foshan United Medical Technologies, Ltd. (Foshan, CN). The FDA issued a Cleared decision on May 11, 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 Foshan United Medical Technologies, Ltd. devices

Submission Details

510(k) Number K172570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2017
Decision Date May 11, 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

Albert Rego, PhD, Inc.
Albert Rego

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 168
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