510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220087Unknown

Edison System

Histosonics, Inc, Plymouth MN / Direct, Unknown
FDA source (opens on fda.gov)

DEN220087 is the FDA 510(k) clearance record for Edison System, a class II device, cleared for HistoSonics, Inc. on under FDA product code QGM (Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation). FDA's definition for product code QGM reads: "This device uses focused ultrasound to mechanically ablate soft tissue. The device is not intended to thermally ablate tissue". FDA records list 4 510(k) clearances for HistoSonics, Inc., from to . As of , FDA records show no recalls naming DEN220087.

Clearance record

Decision date
Received
(308 days to decision)
Product code
QGM Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
Regulation
21 CFR 878.4405
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
HistoSonics, Inc. 16305 36th Ave. N., Plymouth MN
Third party review
No

Clearances, product code QGM

Trailing 12 months

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

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