Cleared Traditional

K103245 - CELSTAT (FDA 510(k) Clearance)

K103245 · Baxter Healthcare Corp · General & Plastic Surgery device
Mar 2011
Decision
141d
Days
—
Risk

K103245 is an FDA 510(k) clearance for the CELSTAT. This device is classified as a Hemostatic Wound Dressing Without Thrombin Or Other Biologics.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 23, 2011, 141 days after receiving the submission on November 2, 2010.

This device falls under the General & Plastic Surgery FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..

Submission Details

510(k) Number K103245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2010
Decision Date March 23, 2011
Days to Decision 141 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class —
Definition To Temporarily Control Bleeding And Cover External Wounds.