FDA product code PTE

Endoscopic Morcellator Gastroenterology

Obstetrics/Gynecology·Class 2·21 CFR 884.1690
US regulatory classifications
US Product Code (FDA)
PTE
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 884.1690
View CFR Regulation →
Medical specialty
Obstetrics/Gynecology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

For use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following EMR (Endoscopic Mucosal Resection)

Search keywords
About this record

Endoscopic Morcellator Gastroenterology is a medical device type in the Obstetrics/Gynecology 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.