510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974232Substantially Equivalent

Essential Shaver System

Gyrus Ent LLC, Bartlett TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974232 is the FDA 510(k) clearance record for ESSENTIAL SHAVER SYSTEM, a class I device, cleared for Gyrus Ent LLC on under FDA product code EQJ (Bur, Ear, Nose And Throat). FDA records list 28 510(k) clearances for Gyrus Ent LLC, from to . As of , FDA records show no recalls naming K974232.

Clearance record

Decision date
Received
(61 days to decision)
Product code
EQJ Bur, Ear, Nose And Throat
Regulation
21 CFR 874.4140
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Gyrus Ent LLC 2925 Appling Rd., Bartlett TN
510(k) summary
Summary
Third party review
No

Clearances, product code EQJ

Trailing 12 months

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

FDA records show no clearances under product code EQJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EQJ, 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