FDA Registration Active 🇺🇸 United States

3.2-PED-BRO-O EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Bronchoscope

Reg #: 3011697028 · FEI: 3011697028 · Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1

Registration Details

Registration Name
INTERSCOPE, INC.
Registration Number
3011697028
FEI Number
3011697028
Status
Active
Expiry Year
2025
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
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

Proprietary Names

3.2-PED-BRO-O EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter – Bronchoscope 3.2-EPR-BRO-O EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter – Bronchoscope ESS-CONSOLE EndoRotor® EndoSurgery System - Console EPR-TRAP EndoRotor® Specimen Trap

Establishment Types

Manufacture Medical Device