Identifiers
- 510(k) Number
- K120590 FDA 510(k)
- FDA Product Code
- PDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1820 FDA 510(k)
- Regulation Number
- 874.1820 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dilator Tube Set is a neurosurgical nerve locator device classified under medical specialty Ear, Nose, Throat. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA.
The device is supplied sterile and designated for single use. It is manufactured by Koros USA, Inc. and holds FDA 510(k) authorization under K-number K120590, with product code PDQ and regulation number 874.1820.
Frequently asked questions
What is the Dilator Tube Set used for?
The Dilator Tube Set is a neurosurgical nerve locator device intended for use in Ear, Nose, and Throat (ENT) procedures to assist in identifying nerves during surgery, based on its classification and specialty designation in the device data.
Is the Dilator Tube Set sterile and single-use?
Yes, the device is supplied sterile and designated for single use, as explicitly stated in the description, meaning it is intended to be used once and then discarded to prevent cross-contamination.
What regulatory authorization does the Dilator Tube Set have?
The device received traditional 510(k) clearance from the FDA under K-number K120590, is substantially equivalent to a predicate device, and is classified under product code PDQ and regulation number 874.1820 for neurosurgical nerve locators in the ENT specialty.
Who manufactures the Dilator Tube Set and where is it located?
The Dilator Tube Set is manufactured by Koros USA, Inc., located at 610 Flinn Ave., Moorepark, CA 93021, as indicated in the manufacturer and address fields of the device data.
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: KOROS U.S.A., INC. LD-109 Dilator Tube Set, Single Use, Sterile, K120590 FDA 510 (k) - DILATOR TUBE SET | Koros USA, Inc., AccessGUDID - DEVICE: Dilator Tube Set, Single Use, Sterile ..., Dilator Tube Set, Single Use, Sterile - BEUDAMED
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120590 | Class II | Active |
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Manufacturer
- Manufacturer
- Koros USA, Inc.
Sources (1)
- FDA 510(k) K120590 24 fields · synced Sep 26, 2026