Dynarex Eye Cups
FDA 510(k) K151575 · Dynarex Corporation
510(k) numberK151575
Submission
- Device name
- Dynarex Eye Cups
- Applicant
- Dynarex Corporation
Orangeburg, NY, US - Received
- June 11, 2015
- Decision date
- September 1, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LXQ – Cup, Eye
- Device class
- Unclassified
Other 510(k)s with product code LXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140409 | Flents Plastic Eye Wash CupLXQ · Traditional | Apothecary Products, Inc. | 07/09/2014SE |
| K051414 | Eye Cup, Sterile 1 and Non SterileLXQ · Traditional | Tollot Pty.Ltd.(Aaxis Pacific) | 06/16/2005SE |
| K971134 | Vista EyeshowerLXQ · Traditional | John Branch | 11/04/1997SE |
| K881369 | Advance Diagnostics Disposable EyecupLXQ · Traditional | Advantage Diagnostics Corp. | 05/13/1988SE |
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| K102637 | Dynarex Ultrasound GelMUI · Traditional | 02/16/2011SE |
| K092488 | Dynarex Sterile Lubricating JellyKMJ · Traditional | 12/18/2009SE |
| K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…KNT · Traditional | 01/09/2009SE |
| K081569 | Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with…LZA · Abbreviated | 09/12/2008SE |
| K052743 | Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921CBP · Traditional | 12/22/2005SE |
| K052314 | Dynarex Vaginal Specula 4900, Models 4911-SMALL, 4912-MEDIUM, 4913-LARGEHIB · Traditional | 11/09/2005SE |
| K012816 | Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414FRO · Traditional | 10/17/2002SE |
Questions and answers
When was Dynarex Eye Cups cleared by the FDA?
Dynarex Eye Cups (K151575) received a 510(k) decision of Substantially Equivalent on September 1, 2015, 82 days after the submission was received.
What is the product code of K151575?
The FDA product code is LXQ – Cup, Eye, a Unclassified device.