K123836

Substantially Equivalent

QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN

Applicant: Surgical Specialties Corp. Dba Angiotech
Product code: GAM
Advisory panel: General, Plastic Surgery
Date received: 2012-12-13
Decision date: 2012-12-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Reading, PA, US

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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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