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Endoscopic Morcellator Gastroenterology

FDA product code PTE · 2 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.1690
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-04-18 – 2019-01-03

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

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