Dynarex Eye Cups
FDA 510(k) clearance K151575 · decided 2015-09-01
Clearance details
- K-number
- K151575
- Device name
- Dynarex Eye Cups
- Applicant
- Dynarex Corporation
- Decision
- Substantially Equivalent
- Date received
- 2015-06-11
- Decision date
- 2015-09-01
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- LXQ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Orangeburg, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FLENTS PLASTIC EYE WASH CUP (K140409) | Apothecary Products, Inc. | 2014-07-09 |
| EYE CUP, STERILE 1 AND NON STERILE (K051414) | Tollot Pty.Ltd.(Aaxis Pacific) | 2005-06-16 |
| VISTA EYESHOWER (K971134) | John Branch | 1997-11-04 |
| ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (K881369) | Advantage Diagnostics Corp. | 1988-05-13 |
Recalls involving this device
No recalls on record reference this clearance.