Lotus Series 4 Ultrasonic Surgical System & Accessories— 510(k) K151101

Substantially Equivalent

Sra Developments, Ltd.

FDA 510(k) clearance K151101 for Lotus Series 4 Ultrasonic Surgical System & Accessories, Substantially Equivalent on 2015-07-17. Applicant: Sra Developments, Ltd..

Clearance details

Applicant: Sra Developments, Ltd.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2015-04-24
Decision date: 2015-07-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Ashburton, Devon, GB

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.