510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K082828Substantially Equivalent

Suturtek 360 Degree Sternal Closure Device

Suturtek Incorporated, Acton MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082828 is the FDA 510(k) clearance record for SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE, a class II device, cleared for Suturtek Incorporated on under FDA product code GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile). FDA records list 4 510(k) clearances for Suturtek Incorporated, from to . As of , FDA records show no recalls naming K082828.

Clearance record

Decision date
Received
(19 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
Suturtek Incorporated 6 Brookside Cir., Acton MA
510(k) summary
Summary PDF
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