EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filt…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181127 FDA 510(k)
- FDA Product Code
- PTE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1690 FDA 510(k)
- Regulation Number
- 884.1690 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is an endoscopic morcellator for gastroenterology, classified as a Class II medical device under regulation number 884.1690. It consists of a power console, catheters, specimen trap, filter set, and foot control, designed for endoscopic procedures.
It is supplied as a system including a power console with foot control, a specimen trap with a filter, and single-use flexible catheters. The device is used in endoscopic airway and gastrointestinal procedures for tissue dissection, resection, and collection, and is authorized under FDA 510(k) clearance K181127.
Frequently asked questions
What is the EndoRotor system used for?
The EndoRotor system is used in endoscopic airway and gastrointestinal procedures for tissue dissection, resection, and collection, enabling minimally invasive removal of tissue samples during gastroenterology interventions.
How is the EndoRotor system supplied and what components are included?
The system is supplied as a complete set including a power console with foot control, a specimen trap with an integrated filter, and single-use flexible catheters, designed for single-procedure use with disposable catheter components.
Are the catheters in the EndoRotor system reusable or single-use?
The catheters are single-use devices, meaning they are intended for one procedure only and must be discarded after use to prevent cross-contamination and ensure optimal performance.
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. Sources consulted: Interscope Med Endorotor Catheter, EndoRotor® Procedure — Interscope Medical, EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181127 | Class II | Active |
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Manufacturer
- Manufacturer
- Interscope, Inc
- FDA Applicant
- Interscope, Inc.
Sources (1)
- FDA 510(k) K181127 24 fields · synced Sep 26, 2026