510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K141206Substantially Equivalent

Edwards Lifesciences Thruport Knotting System

Edwards Lifesciences LLC, Draper UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141206 is the FDA 510(k) clearance record for EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming K141206.

Clearance record

Decision date
Received
(252 days to decision)
Product code
GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Regulation
21 CFR 878.5010
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Edwards Lifesciences, LLC 12050 Lone Peak Pkwy., Draper UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAW

Trailing 12 months
1 clearance under product code GAW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260