SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS— 510(k) K040602

Name: FDA 510(k) clearance K040602
Creator: U.S. Food and Drug Administration
Published: 2004-05-10

Substantially Equivalent

Design Standards Corp.

FDA 510(k) clearance K040602 for SURELINE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, Substantially Equivalent on 2004-05-10. Applicant: Design Standards Corp.. Device class: 2.

Clearance details

Applicant: Design Standards Corp.
Product code: Code FZP
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2004-03-08
Decision date: 2004-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlestown, NH, US

Download summary PDF View on FDA.gov ↗

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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.