DeviceClearance

Product code GAP— General, Plastic Surgery

SOFSILK SUTURE

Classification name
Suture, Nonabsorbable, Silk
Device class
Class 2
Regulation
21 CFR 878.5030
Advisory panel
General, Plastic Surgery
Total cleared
41
First cleared
Most recent

Market context for product code GAP

FDA has cleared 41 devices under product code GAP between 1976 and 2024, filed by 34 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 GAP

Adverse events under product code GAP

product code GAP
Death
3
Injury
491
Malfunction
2,253
Total
2,747

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 GAP

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