HEM-O-LOK XL CLIP— 510(k) K030311

Name: FDA 510(k) clearance K030311
Creator: U.S. Food and Drug Administration
Published: 2003-02-26

Substantially Equivalent

Weck

FDA 510(k) clearance K030311 for HEM-O-LOK XL CLIP, Substantially Equivalent on 2003-02-26. 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: 2003-01-30
Decision date: 2003-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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K251054 — Hem-o-lok PurplePlus Large Polymer Ligating Clips2025-07-03

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K021808 — WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER2002-08-14

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 →

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