DeviceClearance

Product code GAR— General, Plastic Surgery

ARTELON SURGICAL SUTURE

Classification name
Suture, Nonabsorbable, Synthetic, Polyamide
Device class
Class 2
Regulation
21 CFR 878.5020
Advisory panel
General, Plastic Surgery
Total cleared
57
First cleared
Most recent

Market context for product code GAR

FDA has cleared 57 devices under product code GAR between 1990 and 2026, filed by 43 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 GAR

Adverse events under product code GAR

product code GAR
Injury
422
Malfunction
3,386
Other
4
Total
3,812

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 GAR

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