510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K013059Substantially Equivalent

Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures)

Stony Brook Surgical Innovations, Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013059 is the FDA 510(k) clearance record for STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES), a class II device, cleared for Stony Brook Surgical Innovations, Inc. on under FDA product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile). FDA records list 2 510(k) clearances for Stony Brook Surgical Innovations, Inc., from to . As of , FDA records show no recalls naming K013059.

Clearance record

Decision date
Received
(41 days to decision)
Product code
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Regulation
21 CFR 878.4495
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Stony Brook Surgical Innovations, Inc. 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary
Third party review
No

Clearances, product code GAQ

Trailing 12 months

FDA records hold no clearances under product code GAQ in the trailing twelve months.

FDA records show no clearances under product code GAQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GAQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260