Endoscopic Morcellator Gastroenterology
The Endoscopic Morcellator Gastroenterology is an endoscopic device used by trained gastroenterologists to resect and remove residual tissue from peripheral margins following Endoscopic Mucosal Resection (EMR), a procedure for removing superficial gastrointestinal lesions. It is classified as FDA Class 2 under 21 CFR 884.1690 in the Obstetrics/Gynecology specialty (reviewed by the Gastroenterology and Urology panel), requiring 510(k) premarket notification. Product code PTE; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PTE
- Device Class
- FDA class 2
- Regulation Number
- 884.1690
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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)
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.