EndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- EndoRotor Catheter 6.0-PED-EGD EUDAMEDEndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter FDA UDI
- Generic Name
- Tissue morcellation system handpiece, line-powered FDA UDI
- Device Name
- EndoRotor Console EUDAMEDEndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter FDA UDI
- Model / Reference
- 6.0-PED-EGD EUDAMEDFDA UDIESS-CONSOLE EUDAMED
- Description
- EndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter FDA UDI
Identifiers
- Catalog Number
- 6.0-PED-EGD FDA UDI
- Primary DI / UDI-DI
- 00854172008100 EUDAMEDFDA UDI
- Basic UDI-DI
- 0854172008EndoRotor7L EUDAMED
- Direct Marketing DI
- 00854172008100 EUDAMED
- 510(k) Number
- DEN200016 FDA UDI
- FDA Product Code
- QNE FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Tissue morcellation system handpiece, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4330 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Tissue morcellation system handpiece, line-powered
EndoRotor® 6.0mm Powered Endoscopic Debridement (PED) Catheter by Interscope, Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Tissue morcellation system handpiece, line-powered.
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Cleared under the same submission
DEN200016 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Interscope, Inc
Sources (2)
- FDA UDI 11297abf-cb57-4e55-a85b-65269c185a2b 36 fields · synced Jul 14, 2026
- EUDAMED 2cb11455-13bf-457c-80ec-4af7492802f1 61 fields · synced Jul 14, 2026