PTS

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Product code

PTS

Device name

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K) Exempt

FDA classification definition

This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.

Definition text from the FDA device classification database (U.S. federal government work, public domain).