Identifiers
- 510(k) Number
- K180766 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Endiscope Cervical is an arthroscope device designed for medical procedures. It is classified under product code HRX and falls under Class II special controls.
The device is manufactured by Elliquence, LLC and received FDA 510(k) clearance on June 11, 2018. It is supplied as a single-use device and is not indicated for MRI use. The device is stored according to manufacturer specifications and is authorized for use in orthopedic procedures.
Frequently asked questions
What is the Endiscope Cervical used for?
The Endiscope Cervical is an arthroscope device designed for medical procedures, specifically authorized for use in orthopedic procedures. It is classified under product code HRX and falls under Class II special controls.
Is the Endiscope Cervix reusable or single-use?
The Endiscope Cervical is supplied as a single-use device, meaning it is designed for one-time use only and should not be reused for any patient or procedure.
What regulatory approvals does the Endiscope Cervical have?
The Endiscope Cervical received FDA 510(k) clearance on June 11, 2018, with the K number K180766. It is classified under product code HRX and falls under Class II special controls.
How should the Endiscope Cervical be stored?
The Endiscope Cervical should be stored according to the manufacturer's specifications to maintain its integrity and functionality until use.
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: Endiscope, Endiscope Cervical (K180766) — FDA 510(k) | Innolitics, K180766 - Endiscope | FDA 510 (k) | Elliquence, LLC, Endiscope, Endiscope Cervical 510(k) K180766 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180766 | Class II | Active |
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Manufacturer
- Manufacturer
- Elliquence, Llc
Sources (1)
- FDA 510(k) K180766 24 fields · synced Sep 23, 2026