Cleared Traditional

K093729 - GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV D...

K093729 · Hemcon Medical Technologies Europe, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
187d
Days
-
Risk

K093729 is an FDA 510(k) clearance for the GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA.... Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hemcon Medical Technologies Europe, Ltd. (Portland, US). The FDA issued a Cleared decision on June 8, 2010 after a review of 187 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 Hemcon Medical Technologies Europe, Ltd. devices

FDA 510(k) Submission Details - K093729

510(k) Number K093729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2009
Decision Date June 08, 2010
Days to Decision 187 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 115d · This submission: 187d
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 31
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K093729.
Axiostat Chitosan Hemostatic Dressing
K172324 · Advamedica, Inc. · Feb 2018
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012
CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004