Cleared Traditional

K110386 - CELOX RAPID GAUZE

K110386 · Medtrade Products , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
89d
Days
-
Risk

K110386 is an FDA 510(k) clearance for the CELOX RAPID GAUZE. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on May 10, 2011 after a review of 89 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.

View all Medtrade Products , Ltd. devices

FDA 510(k) Submission Details - K110386

510(k) Number K110386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2011
Decision Date May 10, 2011
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 117
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K110386.
CORELEADER HEMO-PAD MODEL CPII 02030
K102944 · Coreleader Biotech Co., Ltd. · Sep 2011
GUARDACARE
K103641 · Hem Con Medical Technologies, Inc. · Jun 2011
CHITOGAUZE FUSION
K111163 · Hem Con Medical Technologies, Inc. · May 2011
CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
NASAL CEASE
K102742 · Catalina, Inc. · Feb 2011
CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI
K102965 · Medtrade Products , Ltd. · Dec 2010