Cleared Traditional

K173005 - SURECELL Gelling Fiber Wound Dressing

K173005 · Jiangsu Newvalue Medical Producst Co.,Ltd · General & Plastic Surgery device
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May 2018
Decision
240d
Days
-
Risk

K173005 is an FDA 510(k) clearance for the SURECELL Gelling Fiber Wound Dressing. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Jiangsu Newvalue Medical Producst Co.,Ltd (Taizhou, CN). The FDA issued a Cleared decision on May 25, 2018 after a review of 240 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.

View all Jiangsu Newvalue Medical Producst Co.,Ltd devices

FDA 510(k) Submission Details - K173005

510(k) Number K173005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date May 25, 2018
Days to Decision 240 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
125d slower than avg
Panel avg: 115d · This submission: 240d
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)

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