Flex Robotic System and Flex Transabdominal Drive— 510(k) K172796

Substantially Equivalent

Medrobotics Corporation

FDA 510(k) clearance K172796 for Flex Robotic System and Flex Transabdominal Drive, Substantially Equivalent on 2018-01-18. Applicant: Medrobotics Corporation.

Clearance details

Applicant: Medrobotics Corporation
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2017-09-15
Decision date: 2018-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.