DeviceClearance

Product code MQR— General, Plastic Surgery

EVOLUTION COLONIC STENT SYSTEM

Classification name
Stent, Colonic, Metallic, Expandable
Device class
Class 2
Regulation
21 CFR 878.3610
Advisory panel
General, Plastic Surgery
Total cleared
16
First cleared
Most recent

Market context for product code MQR

FDA has cleared 16 devices under product code MQR between 1996 and 2024, filed by 7 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

Top applicants under product code MQR

Adverse events under product code MQR

product code MQR
Death
11
Injury
149
Total
160

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 MQR

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