Cleared Traditional

K102946 - CORELEADER COLLA-PAD MODEL CS 03030

K102946 · Coreleader Biotech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
228d
Days
-
Risk

K102946 is an FDA 510(k) clearance for the CORELEADER COLLA-PAD MODEL CS 03030. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Coreleader Biotech Co., Ltd. (Taipei, Taiwan, TW). The FDA issued a Cleared decision on May 20, 2011 after a review of 228 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 - K102946

510(k) Number K102946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date May 20, 2011
Days to Decision 228 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
113d slower than avg
Panel avg: 115d · This submission: 228d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

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

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

All 182
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K102946.
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