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)
| Device Type ID | 2166 |
| Device Name | Endoscopic Morcellator Gastroenterology |
| Physical State | Rotating, Cutting Cannula With Aspiration Of Tissue |
| Technical Method | Mechanical Removal Of Gastrointestinal Tissue |
| Target Area | Gastrointestinal Tract |
| Regulation Description | Hysteroscope And Accessories. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.1690 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTE |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2166 |
| Device | Endoscopic Morcellator Gastroenterology |
| Product Code | PTE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hysteroscope And Accessories. |
| CFR Regulation Number | 884.1690 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INTERSCOPE., INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |