DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS— 510(k) K981239

Substantially Equivalent

Deroyal Surgical

FDA 510(k) clearance K981239 for DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS, Substantially Equivalent on 1998-05-14. Applicant: Deroyal Surgical.

Clearance details

Applicant: Deroyal Surgical
Product code: Code FZP
Advisory panel: General, Plastic Surgery
Date received: 1998-04-03
Decision date: 1998-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maynardville, TN, US

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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.