FDA product code PTS

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Gastroenterology, Urology·Class 2·21 CFR 876.1500
US regulatory classifications
US Product Code (FDA)
PTS
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.1500
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.