FDA Device Establishments · JSON-LD · Markdown
FEI 3011697028 · Manufacture Medical Device · Status: Active
| FEI Number | 3011697028 |
|---|---|
| Owner / Operator | INTERSCOPE., INC (#10054826) |
| Address | 200 Commerce Dr., Northbridge, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PTE |
| Regulation § (21 CFR) | 884.1690 |
| Proprietary names | 3.2-EPR-EGD-F EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Gastroscope Fuji; 3.2-EPR-EGD-OP EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Gastroscope Olympus/Pentax; 6-EPR-EGD EndoRotor® 6mm Endoscopic Powered Resection (EPR) Catheter; CATHGUIDE EndoRotor® Catheter Guide; ESS-CONSOLE EndoRotor® EndoSurgery System - Console; EPR-TRAP EndoRotor® Specimen Trap; 3.2-EPR-COL-O EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Colonoscope Short Olympus; 3.2-EPR-COL-OP EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Colonoscope Long Olympus/Pentax |
Source: openFDA. Public-domain (CC0).