510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860622Substantially Equivalent

Studex Ear Piercing Guns

Onyx Industries, Inc., Harbor City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860622 is the FDA 510(k) clearance record for STUDEX EAR PIERCING GUNS, a class I device, cleared for Onyx Industries, Inc. on under FDA product code JYS (Perforator, Ear-Lobe). FDA records list one 510(k) clearance for Onyx Industries, Inc. As of , FDA records show no recalls naming K860622.

Clearance record

Decision date
Received
(240 days to decision)
Product code
JYS Perforator, Ear-Lobe
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Onyx Industries, Inc. 25311 S. Normandie Ave., Harbor City CA
Third party review
No

Clearances, product code JYS

Trailing 12 months

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

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