510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K061849Substantially Equivalent

Mesoderm

Aa Advanced Technology, Inc., Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061849 is the FDA 510(k) clearance record for MESODERM, a class II device, cleared for Aa Advanced Technology, Inc. on under FDA product code EGJ (Device, Iontophoresis, Other Uses). FDA records list one 510(k) clearance for Aa Advanced Technology, Inc. As of , FDA records show no recalls naming K061849.

Clearance record

Decision date
Received
(304 days to decision)
Product code
EGJ Device, Iontophoresis, Other Uses
Regulation
21 CFR 890.5525
Device class
Class II
Review panel
Physical Medicine
Applicant
Aa Advanced Technology, Inc. 1676 Village Green, Crofton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EGJ

Trailing 12 months

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

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