510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K103245Substantially Equivalent

Celstat

Baxter Healthcare Corporation, Mcgaw Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103245 is the FDA 510(k) clearance record for CELSTAT, cleared for Baxter Healthcare Corp on under FDA product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics). FDA's definition for product code QSY reads: "To temporarily control bleeding and cover external wounds". FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K103245.

Clearance record

Decision date
Received
(141 days to decision)
Product code
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class
Unclassified
Review panel
Unknown
Applicant
Baxter Healthcare Corp 1620 Waukegan Rd., Mcgaw Park IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSY

Trailing 12 months
4 clearances under product code QSY in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QSY, trailing twelve months
MonthClearances
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260