DeviceClearance

Product code GDW— General, Plastic Surgery

AEON Endoscopic Stapler

Classification name
Staple, Implantable
Device class
Class 2
Regulation
21 CFR 878.4750
Advisory panel
General, Plastic Surgery
Total cleared
283
First cleared
Most recent

Market context for product code GDW

FDA has cleared 283 devices under product code GDW between 1976 and 2026, filed by 96 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 GDW

Adverse events under product code GDW

product code GDW
Death
450
Injury
12,684
Malfunction
68,730
Other
6
Total
81,870

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 GDW

1–100 of 283

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