Cleared Traditional

K143124 - KA01 Chitosan Wound Dressing

K143124 · Foshan United Medical Technologies, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
87d
Days
-
Risk

K143124 is an FDA 510(k) clearance for the KA01 Chitosan Wound Dressing. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Foshan United Medical Technologies, Ltd. (Shishan, Nanhai, Foshan, CN). The FDA issued a Cleared decision on January 26, 2015 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Foshan United Medical Technologies, Ltd. devices

FDA 510(k) Submission Details - K143124

510(k) Number K143124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2014
Decision Date January 26, 2015
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Consultant

Namsa
MARCIA PALMA

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 - KGN Wound Dressing With Animal-derived Material(s)

All 179
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K143124.
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PREMVIA
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