510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192834Substantially Equivalent

MECTA Sigma

Mecta Corporation, Suite B OR / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K192834 is the FDA 510(k) clearance record for MECTA Sigma, a class II device, cleared for Mecta Corporation on under FDA product code QGH (Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder). FDA's definition for product code QGH reads: "Catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the...". FDA records list one 510(k) clearance for Mecta Corporation. As of , FDA records show no recalls naming K192834.

Clearance record

Decision date
Received
(207 days to decision)
Product code
QGH Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder
Regulation
21 CFR 882.5940
Device class
Class II
Review panel
Neurology
Applicant
Mecta Corporation 19799 SW 95th Ave., Suite B OR
510(k) summary
Statement
Third party review
No

Clearances, product code QGH

Trailing 12 months

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

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