DeviceClearance

Product code GAQ— General, Plastic Surgery

ACIER SUTURES

Classification name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device class
Class 2
Regulation
21 CFR 878.4495
Advisory panel
General, Plastic Surgery
Total cleared
32
First cleared
Most recent

Market context for product code GAQ

FDA has cleared 32 devices under product code GAQ between 1987 and 2022, filed by 27 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 GAQ

Adverse events under product code GAQ

product code GAQ
Death
3
Malfunction
522
Total
525

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 GAQ

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