510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150882Substantially Equivalent

Edwards Suture Fastening System

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

K150882 is the FDA 510(k) clearance record for Edwards Suture Fastening System, a class I device, cleared for Edwards Lifesciences, LLC on under FDA product code HCF (Instrument, Ligature Passing And Knot Tying). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show one recall naming K150882.

Clearance record

Decision date
Received
(75 days to decision)
Product code
HCF Instrument, Ligature Passing And Knot Tying
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Edwards Lifesciences, LLC One Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HCF

Trailing 12 months

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

FDA records show no clearances under product code HCF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HCF, 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