VISISTAT STAPLER— 510(k) K943719

Name: FDA 510(k) clearance K943719
Creator: U.S. Food and Drug Administration
Published: 1994-08-24

Substantially Equivalent

Pilling Weck, Inc.

FDA 510(k) clearance K943719 for VISISTAT STAPLER, Substantially Equivalent on 1994-08-24. Applicant: Pilling Weck, Inc.. Device class: 1.

Clearance details

Applicant: Pilling Weck, Inc.
Product code: Code GDT
Device class: Class 1
Regulation: 21 CFR 878.4760
Advisory panel: General, Plastic Surgery
Date received: 1994-08-01
Decision date: 1994-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

Download summary PDF View on FDA.gov ↗

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K945520 — HEMOCLIP ECOSYSTEM1995-01-27
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Adverse events under product code GDT

product code GDT

Malfunction: 752
Total: 752

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.