MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER— 510(k) K980617

Substantially Equivalent

Urohealth Systems, Inc.

FDA 510(k) clearance K980617 for MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER, Substantially Equivalent on 1998-04-09. Applicant: Urohealth Systems, Inc..

Clearance details

Applicant: Urohealth Systems, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 1998-01-23
Decision date: 1998-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, MI, US

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.