Flex Robotic System and Flex Transabdominal Drive

FDA 510(k) K172796 · Medrobotics Corporation

Substantially Equivalent

510(k) numberK172796

Submission

Device name
Flex Robotic System and Flex Transabdominal Drive
Applicant
Medrobotics Corporation
Raynham, MA, US
Received
September 15, 2017
Decision date
January 18, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HET – Laparoscope, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1720
Specialty
Obstetrics/Gynecology

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More from 270surgical , Ltd.

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Questions and answers

When was Flex Robotic System and Flex Transabdominal Drive cleared by the FDA?

Flex Robotic System and Flex Transabdominal Drive (K172796) received a 510(k) decision of Substantially Equivalent on January 18, 2018, 125 days after the submission was received.

What is the product code of K172796?

The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.