Weck Hem-o-lok Auto Endo5 Ligating Clip Applier— 510(k) K142777

Name: FDA 510(k) clearance K142777
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K142777 for Weck Hem-o-lok Auto Endo5 Ligating Clip Applier, Substantially Equivalent on 2014-12-19. Applicant: Teleflexmedical, Inc.. Device class: 2.

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code FZP
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2014-09-26
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FZP

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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

More clearances from Teleflexmedical, Inc.

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K212077 — Teleflex Rusch SoftSimplastic Foley Catheters2023-07-27
K192324 — Sheridan Spiral-Flex Endotracheal Tubes2019-12-06
K182847 — Hudson RCI Voldyne Volumetric Exerciser2019-07-01
K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter2019-05-24

Adverse events under product code FZP

product code FZP

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 →

Recalls naming K142777

K-number listed on FDA's recall record

Z-0886-2016 — Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures.Class II·Terminated·Teleflex Medical·20160202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142777.

Data sourced from openFDA. This site is unofficial and independent of the FDA.