WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER— 510(k) K021808

Name: FDA 510(k) clearance K021808
Creator: U.S. Food and Drug Administration
Published: 2002-08-14

Substantially Equivalent

Weck

FDA 510(k) clearance K021808 for WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER, Substantially Equivalent on 2002-08-14. Applicant: Weck. Device class: 2.

Clearance details

Applicant: Weck
Product code: Code FZP
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2002-06-03
Decision date: 2002-08-14
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 Weck

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K030311 — HEM-O-LOK XL CLIP2003-02-26

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 K021808

K-number listed on FDA's recall record

Z-0497-2020 — WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clipsClass II·Ongoing·Teleflex Medical·20191004

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021808.

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