TX1 TISSUE REMOVAL SYSTEM— 510(k) K101561

Substantially Equivalent

American Optisurgical, Inc.

FDA 510(k) clearance K101561 for TX1 TISSUE REMOVAL SYSTEM, Substantially Equivalent on 2010-08-27. Applicant: American Optisurgical, Inc..

Clearance details

Applicant: American Optisurgical, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2010-06-04
Decision date: 2010-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.