510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963809Substantially Equivalent

Cool-Zone

Kappler USA, Guntersville AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963809 is the FDA 510(k) clearance record for COOL-ZONE, a class II device, cleared for Kappler USA on under FDA product code FYA (Gown, Surgical). FDA records list 2 510(k) clearances for Kappler USA, from to . As of , FDA records show no recalls naming K963809.

Clearance record

Decision date
Received
(58 days to decision)
Product code
FYA Gown, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kappler USA P.O. Box 218, Guntersville AL
510(k) summary
Summary
Third party review
No

Clearances, product code FYA

Trailing 12 months
10 clearances under product code FYA in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FYA, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20260
April 20262
May 20261
June 20261
July 20261
August 20262
September 20260
October 20260