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EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter FDA UDI
- Generic Name
- Tissue morcellation system handpiece, line-powered FDA UDI
- Device Name
- EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter FDA UDI
- Model / Reference
- 6.0-EPR-EGD FDA UDI
- Description
- EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter FDA UDI
Identifiers
- Catalog Number
- 6.0-EPR-EGD FDA UDI
- Primary DI / UDI-DI
- 00854172008117 FDA UDI
- 510(k) Number
- DEN200016 FDA UDI
- FDA Product Code
- QNE FDA UDI
- GMDN Term
- Tissue morcellation system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tissue morcellation system handpiece, line-powered
EndoRotor® 6.0mm Endoscopic Powered Resection (EPR) Catheter by Interscope, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tissue morcellation system handpiece, line-powered.
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- 2-piece Cleaning Adapter + 4-piece Valve Kit — GA HEALTH COMPANY LIMITED · Class IIa
- Guide Wires — Changzhou Health Microport Medical Device Co., Ltd · Class IIa
- Aveta Disposable Resecting Device 3.9 mm — Meditrina, Inc. · Class II
- 3-piece valve kit — GA HEALTH COMPANY LIMITED · Class I
Cleared under the same submission
DEN200016 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Interscope, Inc
Sources (1)
- FDA UDI eb43c694-cbe3-45a4-a483-193bf68ce38d 36 fields · synced Jun 1, 2026