DeviceClearance

Product code GAT— General, Plastic Surgery

HS Fiber

Classification name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device class
Class 2
Regulation
21 CFR 878.5000
Advisory panel
General, Plastic Surgery
Total cleared
176
First cleared
Most recent

Market context for product code GAT

FDA has cleared 176 devices under product code GAT between 1993 and 2026, filed by 88 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 GAT

Adverse events under product code GAT

product code GAT
Death
19
Injury
4,163
Malfunction
8,646
Other
2
Total
12,830

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 GAT

1–100 of 176

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