DeviceClearance

Product code NEW— General, Plastic Surgery

QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Classification name
Suture, Surgical, Absorbable, Polydioxanone
Device class
Class 2
Regulation
21 CFR 878.4840
Advisory panel
General, Plastic Surgery
Total cleared
66
First cleared
Most recent

Market context for product code NEW

FDA has cleared 66 devices under product code NEW between 2001 and 2026, filed by 38 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 NEW

Adverse events under product code NEW

product code NEW
Death
32
Injury
2,179
Malfunction
8,975
Total
11,186

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 NEW

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