Cleared Traditional

ALGS2 Ag Alginate Wound Dressing Rx (K233111) - FDA 510(k) Clearance

Also marketed or referenced as:
ALGS2 Ag Alginate Wound Dressing OTC ALGS2S Re-enforced Ag Alginate Wound Dressing Rx ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
K233111 · Foshan United Medical Technologies, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
240d
Days
-
Risk

K233111 is an FDA 510(k) clearance for the ALGS2 Ag Alginate Wound Dressing Rx. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Foshan United Medical Technologies, Ltd. (Guangdong Province, CN). The FDA issued a Cleared decision on May 24, 2024 after a review of 240 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 K233111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2023
Decision Date May 24, 2024
Days to Decision 240 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
125d slower than avg
Panel avg: 115d · This submission: 240d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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