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
K160564Substantially Equivalent

TroClose1200

Gordian Surgical, Karmiel, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160564 is the FDA 510(k) clearance record for TroClose1200, a class II device, cleared for Gordian Surgical, Ltd. on under FDA product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). FDA records list 3 510(k) clearances for Gordian Surgical, Ltd., from to . As of , FDA records show one recall naming K160564.

Clearance record

Decision date
Received
(262 days to decision)
Product code
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation
21 CFR 878.4493
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Gordian Surgical, Ltd. 17th Tchelet St., Karmiel, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAM

Trailing 12 months
5 clearances under product code GAM in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GAM, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260