DeviceClearance

Product code GAM— General, Plastic Surgery

QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Classification name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device class
Class 2
Regulation
21 CFR 878.4493
Advisory panel
General, Plastic Surgery
Total cleared
149
First cleared
Most recent

Market context for product code GAM

FDA has cleared 149 devices under product code GAM between 1991 and 2026, filed by 59 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 GAM

Adverse events under product code GAM

product code GAM
Death
45
Injury
5,711
Malfunction
30,744
Other
4
Total
36,504

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 GAM

1–100 of 149

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