Cleared Traditional

K071936 - WOUNDSTAT, MODEL TC1001

K071936 · Traumacure, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
41d
Days
-
Risk

K071936 is an FDA 510(k) clearance for the WOUNDSTAT, MODEL TC1001. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Traumacure, Inc. (Washington, US). The FDA issued a Cleared decision on August 23, 2007 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K071936

510(k) Number K071936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2007
Decision Date August 23, 2007
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
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 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K071936.
PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)
K070520 · Biolife, LLC · Oct 2007
QUIKCLOT EX
K072474 · Z-Medica Corporation · Oct 2007
BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17
K071578 · Lifescience Plus, Inc. · Sep 2007
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
K063190 · Noble Fiber Technologies, Inc. · Aug 2007
HEMCON CHITOFLEX-SURGICAL DRESSING
K071519 · Hemcon, Inc. · Aug 2007
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC
K070175 · Medtrade Products , Ltd. · Jul 2007
K071936 · WOUNDSTAT, MODEL TC1001
Download PDF FDA Summary Traumacure, Inc.