510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863393Substantially Equivalent

Endocater

The Hygenic Company, LLC, Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863393 is the FDA 510(k) clearance record for ENDOCATER, cleared for The Hygenic Corp. on under FDA product code LQY (Locator, Root Apex). FDA records list 16 510(k) clearances for The Hygenic Corp., from to . As of , FDA records show no recalls naming K863393.

Clearance record

Decision date
Received
(281 days to decision)
Product code
LQY Locator, Root Apex
Device class
Unclassified
Review panel
Unknown
Applicant
The Hygenic Corp. 1245 Home Ave., Akron OH
Third party review
No

Clearances, product code LQY

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