DeviceClearance

Product code GEH— General, Plastic Surgery

truFreeze System

Classification name
Unit, Cryosurgical, Accessories
Device class
Class 2
Regulation
21 CFR 878.4350
Advisory panel
General, Plastic Surgery
Total cleared
264
First cleared
Most recent

Market context for product code GEH

FDA has cleared 264 devices under product code GEH between 1976 and 2026, filed by 103 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code GEH

Adverse events under product code GEH

product code GEH
Death
25
Injury
351
Malfunction
901
Total
1,277

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code GEH

1–100 of 264

Data sourced from openFDA. This site is unofficial and independent of the FDA.