Cleared Traditional

K123394 - CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING

K123394 · 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
Jun 2013
Decision
216d
Days
-
Risk

K123394 is an FDA 510(k) clearance for the CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coreleader Biotech Co., Ltd. (New Taipei, Taiwan, TW). The FDA issued a Cleared decision on June 6, 2013 after a review of 216 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 - K123394

510(k) Number K123394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2012
Decision Date June 06, 2013
Days to Decision 216 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
101d slower than avg
Panel avg: 115d · This submission: 216d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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