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

Name: FDA 510(k) clearance K013059
Creator: U.S. Food and Drug Administration
Published: 2001-10-22

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.. Device class: 2.

Clearance details

Applicant: Stony Brook Surgical Innovations, Inc.
Product code: Code GAQ
Device class: Class 2
Regulation: 21 CFR 878.4495
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAQ

view all

K203855 — CoNextions TR Tendon Repair System2022-04-22
K193209 — Wego-Stainless Steel2020-02-19
K172146 — MERISTEEL2018-02-01
K170767 — Surgical Stainless Steel Suture, Stainless Steel Suture2017-11-01
K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE2014-09-25

More clearances from Stony Brook Surgical Innovations, Inc.

view all

K930015 — STERNAL BAND1993-05-19

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.