Cleared Traditional

K071519 - HEMCON CHITOFLEX-SURGICAL DRESSING

K071519 · Hemcon, 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
63d
Days
-
Risk

K071519 is an FDA 510(k) clearance for the HEMCON CHITOFLEX-SURGICAL DRESSING. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hemcon, Inc. (Portland, US). The FDA issued a Cleared decision on August 6, 2007 after a review of 63 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 - K071519

510(k) Number K071519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2007
Decision Date August 06, 2007
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 K071519.
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
WOUNDSTAT, MODEL TC1001
K071936 · Traumacure, Inc. · Aug 2007
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
K063190 · Noble Fiber Technologies, Inc. · Aug 2007
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC
K070175 · Medtrade Products , Ltd. · Jul 2007
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM
K070211 · Hemostasis, LLC · Apr 2007
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER
K070010 · Z-Medica Corporation · Jan 2007
K071519 · HEMCON CHITOFLEX-SURGICAL DRESSING
Download PDF FDA Summary Hemcon, Inc.