Cleared Traditional

K112800 - SUNTOUCH TOPICAL HEMOSTATIC DRESSING

K112800 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
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May 2012
Decision
239d
Days
-
Risk

K112800 is an FDA 510(k) clearance for the SUNTOUCH TOPICAL HEMOSTATIC DRESSING. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Pennington, US). The FDA issued a Cleared decision on May 23, 2012 after a review of 239 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 Huizhou Foryou Medical Devices Co., Ltd. devices

FDA 510(k) Submission Details - K112800

510(k) Number K112800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2011
Decision Date May 23, 2012
Days to Decision 239 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
124d slower than avg
Panel avg: 115d · This submission: 239d
Pathway characteristics
Predicate-based equivalence.

QSY Device Classification - Class 0,

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 77
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K112800.
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CLO-SURPLUS P.A.D.
K112961 · Scion Cardio-Vascular, Inc. · Oct 2011
GUARDACARE
K103641 · Hem Con Medical Technologies, Inc. · Jun 2011