QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN— 510(k) K141778

Substantially Equivalent

Surgical Specialties Corporation

FDA 510(k) clearance K141778 for QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN, Substantially Equivalent on 2014-07-30. Applicant: Surgical Specialties Corporation.

Clearance details

Applicant: Surgical Specialties Corporation
Product code: Code GAM
Advisory panel: General, Plastic Surgery
Date received: 2014-07-02
Decision date: 2014-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Reading, PA, US

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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.