Ellik Evacuator
FDA 510(k)Class II (US FDA 510(k))
by Davol Inc.
Identifiers
- 510(k) Number
- K791306 FDA 510(k)
- FDA Product Code
- KQT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.4370 FDA 510(k)
- Regulation Number
- 876.4370 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ellik Evacuator is a medical device classified as an evacuator in the gastro-urology field. It is designed for the removal of tissue sections during procedures such as transurethral prostatectomy (TURPs) and bladder biopsies.
The device is available in disposable or reusable models with a medium wall and rubber bulb construction. It received FDA 510(k) clearance on August 3, 1979, with product code KQT and is classified as a Class 2 device.
Frequently asked questions
What is the Ellik Evacuator used for?
The Ellik Evacuator is a medical device designed for the removal of tissue sections during procedures such as transurethral prostatectomy (TURPs) and bladder biopsies in the gastro-urology field.
Is the Ellik Evacuator available in different models?
Yes, the Ellik Evacuator is available in both disposable and reusable models, featuring a medium wall and rubber bulb construction to suit different clinical needs and preferences.
What is the regulatory status of the Ellik Evacuator?
The Ellik Evacuator received FDA 510(k) clearance on August 3, 1979, with product code KQT and is classified as a Class 2 device, indicating it meets specific regulatory requirements for safety and effectiveness.
How should the Ellik Evacuator be stored?
The device should be stored according to the manufacturer's instructions, which typically recommend keeping it in a clean, dry environment at room temperature 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: ELLIK EVACUATOR (K791306) — FDA 510 (k) | Innolitics, Wound, Accessories, Ellik Bladder Evacuator, Medium Wall, Rubber Bulb - BD, Class 2 Device Recall Ellik Evacuator - accessdata.fda.gov, Ellik Bladder Evacuator | Medline
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K791306 | Class II | Active |
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Manufacturer
- Manufacturer
- Davol Inc.
- FDA Applicant
- Davol, Inc.
Sources (1)
- FDA 510(k) K791306 24 fields · synced Sep 22, 2026