DeviceClearance

Product code FTL— General, Plastic Surgery

GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

Classification name
Mesh, Surgical, Polymeric
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
336
First cleared
Most recent

Market context for product code FTL

FDA has cleared 336 devices under product code FTL between 1979 and 2026, filed by 121 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 FTL

Adverse events under product code FTL

product code FTL
Death
317
Injury
66,072
Malfunction
1,273
Other
3
Total
67,665

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 FTL

1–100 of 336

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