Cleared Traditional

K143335 - Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)

K143335 · Roosin Medical Devices Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
193d
Days
-
Risk

K143335 is an FDA 510(k) clearance for the Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dress.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Roosin Medical Devices Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on June 1, 2015 after a review of 193 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.

FDA 510(k) Submission Details - K143335

510(k) Number K143335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2014
Decision Date June 01, 2015
Days to Decision 193 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
78d slower than avg
Panel avg: 115d · This submission: 193d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Manton Business and Technology Services
Charles Shen

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 638
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K143335.
MEDIHONEY WOUND DRESSINGS
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DERMAFINE
K140905 · Invado Pharmaceuticals · May 2015
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K150256 · Argentum Medical · Apr 2015