510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894490Substantially Equivalent

Sterile Ultrasound Transmission Gel

Swedish Trade Council USA, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894490 is the FDA 510(k) clearance record for STERILE ULTRASOUND TRANSMISSION GEL, a class II device, cleared for Swedish Trade Council USA on under FDA product code JOT (Electrode, Gel, Electrosurgical). FDA records list 2 510(k) clearances for Swedish Trade Council USA, from to . As of , FDA records show no recalls naming K894490.

Clearance record

Decision date
Received
(79 days to decision)
Product code
JOT Electrode, Gel, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Swedish Trade Council USA 150 N. Michigan Ave., Chicago IL
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