STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)— 510(k) K013059

Substantially Equivalent

Stony Brook Surgical Innovations, Inc.

FDA 510(k) clearance K013059 for STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES), Substantially Equivalent on 2001-10-22. Applicant: Stony Brook Surgical Innovations, Inc..

Clearance details

Applicant: Stony Brook Surgical Innovations, Inc.
Product code: Code GAQ
Advisory panel: General, Plastic Surgery
Date received: 2001-09-11
Decision date: 2001-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.