EndoRotor Console, Catheter, Specimen Trap, Filter Set, Roll Stand
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- EndoRotor Specimen Trap EUDAMEDEndoRotor Console EUDAMEDEndoRotor® Console FDA UDIEndoRotor® Specimen Trap FDA UDI
- Generic Name
- Tissue morcellation system control unit FDA UDISurgical suction system collection container, single-use FDA UDI
- Device Name
- EndoRotor Console EUDAMEDEndoRotor® Specimen Trap FDA UDI
- Model / Reference
- EPR-TRAP EUDAMEDFDA UDIESS-CONSOLE EUDAMEDERC 20-01 FDA UDI
- Description
- EndoRotor® Specimen Trap FDA UDI
Identifiers
- Catalog Number
- ERC 20-01 FDA UDIEPR-TRAP FDA UDI
- Primary DI / UDI-DI
- 00865830000220 EUDAMEDFDA UDI10854172008206 EUDAMEDFDA UDI
- Basic UDI-DI
- 0854172008EndoRotor7L EUDAMED
- Direct Marketing DI
- 10854172008206 EUDAMED00865830000220 EUDAMED
- 510(k) Number
- K190715 FDA 510(k)
- FDA Product Code
- ERL FDA 510(k)PTE FDA UDI
- EMDN Code
- G030899 INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Tissue morcellation system control unit FDA UDISurgical suction system collection container, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 874.4250 FDA 510(k)
- Regulation Number
- 874.4250 FDA 510(k)884.1690 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
Expiration Date
No
Manufacturing Date
Yes
The EndoRotor system is a surgical drill designed for otolaryngology procedures, combining an electric or pneumatic handpiece with accessories for tissue removal and filtration. It is classified as a Class II surgical drill for ear, nose, and throat (ENT) applications, enabling precise bone and tissue resection in endoscopic sinus surgery and related procedures.
The system comprises a console, catheter, specimen trap, filter set, and roll stand, supplied as reusable components for use in sterile operating environments. Each component is intended for single-use or reusable applications, with MRI safety ratings and dimensions specified in the regulatory filings. Authorised under FDA 510K and MDR pathways, the device adheres to regulatory standards for ENT surgical instruments, including the classification under regulation number 874.4250.
Frequently asked questions
What types of procedures is the EndoRotor system designed to assist with in the operating room?
The EndoRotor system is specifically designed for otolaryngology procedures, particularly endoscopic sinus surgery and related ENT applications. It combines an electric or pneumatic handpiece with accessories like the catheter, specimen trap, and filter set to enable precise bone and tissue resection during these surgeries.
Are the components of the EndoRotor system reusable or single-use, and how should they be handled in a sterile environment?
The EndoRotor system components—console, catheter, specimen trap, filter set, and roll stand—are intended for reusable applications when used in sterile operating environments. Proper cleaning, sterilization, and maintenance protocols must be followed to ensure safety and functionality for repeated use.
What regulatory pathways does the EndoRotor system follow, and how does this impact its use in clinical settings?
The EndoRotor system is authorized under the FDA 510K pathway and the EU Medical Device Regulation (MDR). This classification ensures compliance with U.S. and European regulatory standards for surgical drills in ENT procedures, confirming its safety and performance for clinical use in approved markets.
How do I determine the correct size or model of EndoRotor components for my specific surgical needs?
The EndoRotor system includes multiple registration numbers and FEI numbers (e.g., 3003678543, 2649614) that correspond to specific models and configurations. These identifiers help match the correct catheter, filter set, or console to your procedure requirements, ensuring compatibility with your surgical plan.
Can the EndoRotor system be used safely in an MRI environment, and if so, what precautions should be taken?
The EndoRotor system components are designed with MRI safety ratings, meaning they can be used in MRI environments under specific conditions. However, strict adherence to manufacturer guidelines and facility protocols is required to ensure patient and staff safety, as improper handling near MRI machines could pose risks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190715 | Class II | Active |
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Manufacturer
- Manufacturer
- Interscope, Inc
- FDA Applicant
- Interscope, Inc.
Sources (5)
- FDA 510(k) K190715 24 fields · synced Sep 18, 2026
- FDA UDI d7a88cae-4deb-4beb-9b14-84180fd4c0fa 34 fields · synced May 30, 2026
- FDA UDI dbd17598-98fd-4226-9543-2803749da9af 35 fields · synced May 30, 2026
- EUDAMED 9e10c730-e943-4e1f-a84a-adbdf358c371 61 fields · synced Jul 9, 2026
- EUDAMED 2abfbe42-903e-449e-ac7c-844b1591b2c5 61 fields · synced Jul 29, 2026