510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050188Substantially Equivalent

Epiguard

Episafe Medical Devices, Ltd., Somerset MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050188 is the FDA 510(k) clearance record for EPIGUARD, a class II device, cleared for Episafe Medical Devices, Ltd. on under FDA product code JXL (Block, Bite). FDA records list one 510(k) clearance for Episafe Medical Devices, Ltd. As of , FDA records show no recalls naming K050188.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JXL Block, Bite
Regulation
21 CFR 882.5070
Device class
Class II
Review panel
Neurology
Applicant
Episafe Medical Devices, Ltd. 291 Hillside Ave., Somerset MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JXL

Trailing 12 months

FDA records hold no clearances under product code JXL in the trailing twelve months.

FDA records show no clearances under product code JXL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JXL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260