K102944 - CORELEADER HEMO-PAD MODEL CPII 02030 (FDA 510(k) Clearance)

K102944 is an FDA 510(k) clearance for the CORELEADER HEMO-PAD MODEL CPII 02030. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Coreleader Biotech Co., Ltd. (Taipei, Taiwan, TW). The FDA issued a Cleared decision on September 7, 2011 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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