Flex Robotic System and Flex Colorectal Drive— 510(k) K162330

Substantially Equivalent

Medrobotics Corporation

FDA 510(k) clearance K162330 for Flex Robotic System and Flex Colorectal Drive, Substantially Equivalent on 2017-05-04. Applicant: Medrobotics Corporation.

Clearance details

Applicant: Medrobotics Corporation
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2016-08-19
Decision date: 2017-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.