510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904418Substantially Equivalent

Ultrasound Coupling Gel

Geno Laboratories, Baton Rouge LA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904418 is the FDA 510(k) clearance record for ULTRASOUND COUPLING GEL, a class II device, cleared for Geno Laboratories on under FDA product code JOT (Electrode, Gel, Electrosurgical). FDA records list one 510(k) clearance for Geno Laboratories. As of , FDA records show no recalls naming K904418.

Clearance record

Decision date
Received
(137 days to decision)
Product code
JOT Electrode, Gel, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Geno Laboratories 9989 Burbank Dr., Suite 11, Baton Rouge LA
Third party review
No

Clearances, product code JOT

Trailing 12 months

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

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