510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K013990Substantially Equivalent

Lifestitch Suturing Device

Edwards Lifesciences LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013990 is the FDA 510(k) clearance record for LIFESTITCH SUTURING DEVICE, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming K013990.

Clearance record

Decision date
Received
(86 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Edwards Lifesciences, LLC One Edwards Way, Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code GAT

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