Data / Medical devices / United States / Interscope, Inc.
Interscope, Inc.: FDA-registered device maker in Northbridge, MA, United States, 3 510(k) clearances
Interscope, Inc. is registered with the FDA (registration 3011697028) in Northbridge, MA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 23, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011697028
- Address
- 200 Commerce Dr., Northbridge, MA, United States, 01534
- Owner or operator
- INTERSCOPE., INC (10054826)
- Roles
- Manufacturer
- First device listed
- December 17, 2020
- Registered through
- 2026
- Brand names listed
- 3.2-EPR-BRO-O EndoRotor® 3.2mm Endoscopic Powered Resection (EPR) Catheter Bronchoscope, 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, 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, 3.2-PED-BRO-O EndoRotor® 3.2mm Powered Endoscopic Debridement (PED) Catheter Bronchoscope, 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 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Morcellator Gastroenterology | PTE | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Pancreatic Debridement Device | QNE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2020 | DEN200016 | EndoRotor Device | QNE | Unknown | Interscope, Inc. | accessdata.fda.gov |
| December 13, 2019 | K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand | ERL | Substantially Equivalent | Interscope, Inc. | accessdata.fda.gov |
| January 3, 2019 | K181127 | EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control | PTE | Substantially Equivalent | Interscope, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 23, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.