510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031036Substantially Equivalent

Gebauer's Skin Refrigerant (Mist Spray), Model P/n 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/n-03

Gebauer Co, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031036 is the FDA 510(k) clearance record for GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03, cleared for Gebauer Co. on under FDA product code MLY (Vapocoolant Device). FDA records list 10 510(k) clearances for Gebauer Co., from to . As of , FDA records show one recall naming K031036.

Clearance record

Decision date
Received
(100 days to decision)
Product code
MLY Vapocoolant Device
Device class
Unclassified
Review panel
Unknown
Applicant
Gebauer Co. 9410 St. Catherine Ave., Cleveland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MLY

Trailing 12 months
2 clearances under product code MLY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MLY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260