HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240— 510(k) K993157

Clearance details

Applicant

Weck Closure Systems

Product code

Code FZP

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

1999-09-21

Decision date

1999-12-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Research Triangle Park, NC, US

• K254231 — Inno-Hook Disposable Clip Appliers (Ligating Clips) and Inno-Hook Ligating Clips2026-07-20
• K253781 — InnoClip Clip Applier2025-12-22
• K253903 — InnoClip Disposable Clip Applier2025-12-22
• K250643 — Disposable Polymer Ligation Clips2025-11-20
• K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips2025-07-03

• K011660 — WECK CARDIAC PACING WIRES2001-08-21
• K003337 — HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 5442402000-12-21
• K982941 — HEM-O-LOK MODEL NUMBERS 523900, 5239701998-11-19
• K982944 — HEM-O-LOCK, MODEL 5239351998-11-19
• K982313 — HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS1998-08-10

Death

11

Injury

726

Malfunction

10,830

Other

1

Total

11,568

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-0078-2013 — Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of surgical procedures. Vessels and tissue structures in the range of 0.5 to 16 mm can be effectively ligated with Hem-o-lok clips.Class II·Terminated·Teleflex Medical·20120925

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993157.