Cleared Traditional

K021062 - CHITO-SEAL

K021062 · Abbott Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
143d
Days
-
Risk

K021062 is an FDA 510(k) clearance for the CHITO-SEAL. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Abbott Vascular, Inc. (Redwood, US). The FDA issued a Cleared decision on August 23, 2002 after a review of 143 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.

View all Abbott Vascular, Inc. devices

FDA 510(k) Submission Details - K021062

510(k) Number K021062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date August 23, 2002
Days to Decision 143 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
28d slower than avg
Panel avg: 115d · This submission: 143d
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 77
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K021062.
HEMCON BANDAGE AND HEMCON BANDAGE OTC
K043050 · Hemcon, Inc. · Jun 2005
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
K050769 · Z-Medica Corporation · Apr 2005
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004
3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214
K982638 · Innovative Technologies , Ltd. · Aug 1998
SORBASTACE
K965034 · Hemostace, LLC · Apr 1998
KALTOSTAT WOUND DRESSING
K910059 · Calgon Vestal Div. · Mar 1991