Cleared Traditional

K102742 - NASAL CEASE

K102742 · Catalina, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
133d
Days
-
Risk

K102742 is an FDA 510(k) clearance for the NASAL CEASE. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Catalina, Inc. (Richmond, US). The FDA issued a Cleared decision on February 2, 2011 after a review of 133 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K102742

510(k) Number K102742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2010
Decision Date February 02, 2011
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 K102742.
CHITOGAUZE FUSION
K111163 · Hem Con Medical Technologies, Inc. · May 2011
CELOX RAPID GAUZE
K110386 · Medtrade Products , Ltd. · May 2011
CELSTAT
K103245 · Baxter Healthcare Corp · Mar 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
NEXSTAT (TM) TOPICAL HEMOSTAT POWDER
K102459 · Hemostasis, LLC · Dec 2010
CHITOGAUZE
K102546 · Hem Con Medical Technologies, Inc. · Nov 2010
K102742 · NASAL CEASE
Download PDF FDA Summary Catalina, Inc.