PTE
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Endoscopic Morcellator Gastroenterology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1690
- Medical specialty
- Obstetrics/Gynecology
- FDA 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)
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control (K181127) | Interscope, Inc. | 2019-01-03 |
| EndoRotor (K170120) | Interscope, Inc. | 2017-04-18 |
Track PTE automatically
Every clearance here is in the API, with alerts when new ones post.