Edwards Suture Fastening System— 510(k) K150882

Clearance details

Applicant

Edwards Lifesciences, LLC

Product code

Code HCF

Device class

Class 1

Regulation

21 CFR 878.4800

Advisory panel

General, Plastic Surgery

Date received

2015-04-02

Decision date

2015-06-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

• K931379 — MICROVASIVE INSURG LAPTIE SUTURE LIGATOR1993-07-13
• K851452 — VALTRAC PURSESTING DEVICE1985-06-12
• K841617 — STROVER HOOK1984-08-27
• K790577 — HEMORRHOIDAL LIGATOR1979-04-23

• K251326 — Respiration Rate algorithm2026-06-11
• K253186 — HemoSphere Nano Monitor (HSNANO1)2026-02-24
• K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)2025-09-23
• K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)2025-09-17
• K242518 — Hypertension Prediction Index (HePI) Algorithm2025-05-15

Death

6

Other

1

Total

7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1575-2016 — Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.Class II·Terminated·Mindray DS USA, Inc. dba Mindray North America·20160309

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150882.