FDA Registration
Active
🇺🇸 United States
INTERSCOPE, INC.
Reg #: 3011697028
·
FEI: 3011697028
·
Expires 2026
Products
3
Proprietary Names
17
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- INTERSCOPE, INC.
- Registration Number
- 3011697028
- FEI Number
- 3011697028
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 200 Commerce Dr.
- City
- Northbridge
- State
- MA
- ZIP
- 01534
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190715
Owner / Operator
- Firm Name
- INTERSCOPE., INC
- Operator Number
- 10054826
- Address
- 200 Commerce Dr
- City
- Northbridge
- State
- MA
- Postal Code
- 01534
- Country
- US
- Correspondent
- JEFFERY RYAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2020-12-17 |
| Endoscopic Morcellator Gastroenterology | PTE | Class 2 | Obstetrics/Gynecology | No | 2022-02-15 |
| Endoscopic Pancreatic Debridement Device | QNE | Class 2 | Gastroenterology, Urology | No | 2021-02-18 |
Proprietary Names
EPR-TRAP EndoRotor® Specimen Trap
ESS-CONSOLE EndoRotor® EndoSurgery System - Console
3.2-EPR-BRO-O EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Bronchoscope
3.2-PED-BRO-O EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter Bronchoscope
3.2-EPR-COL-OP EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Colonoscope Long Olympus/Pentax
CATHGUIDE EndoRotor® Catheter Guide
3.2-EPR-EGD-F EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Gastroscope Fuji
6-EPR-EGD EndoRotor® 6mm Endoscopic Powered Resection (EPR) Catheter
3.2-EPR-COL-O EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Colonoscope Short Olympus
3.2-EPR-EGD-OP EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Gastroscope Olympus/Pentax
3.7-PED-EGD-F EndoRotor® 3.7mm Powered Endoscopic Debridement (PED) Catheter Gastroscope Fuji
3.2-PED-EGD-OP EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter Gastroscope Olympus/Pentax
3.2-PED-COL-OP EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter Colonoscope Long Olympus/Pentax
3.2-PED-EGD-F EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter Gastroscope Fuji
PED-PURGE EndoRotor® Purge Kit
3.7-PED-EGD-OP EndoRotor® 3.7mm Powered Endoscopic Debridement (PED) Catheter Gastroscope Olympus/Pentax
6-PED-EGD EndoRotor® 6mm Powered Endoscopic Debridement (PED) Catheter
Establishment Types
Manufacture Medical Device