KleenGel Dispenser
FDA 510(k) clearance K143177 · decided 2015-09-14
Clearance details
- K-number
- K143177
- Device name
- KleenGel Dispenser
- Applicant
- Kleengel, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-11-04
- Decision date
- 2015-09-14
- Days to decision
- 314 days
- Clearance type
- Traditional
- Product code
- KYX
- Device class
- 1
- Regulation number
- 880.6430
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Boca Raton, FL, 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 |
|---|---|---|
| CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSER (K980109) | Sangstat Medical Corp. | 1998-08-18 |
| CANYONS BI-DIRECTIONAL CHECK VALVE (K954181) | Canyon Medical Products | 1995-11-29 |
| BOTTLE ADAPTER (K830571) | Burron Medical Products, Inc. | 1983-03-24 |
| MULTI-AD FLUID DISPENSING PUMP MP-3000 (K801008) | Burron Medical Products, Inc. | 1980-06-02 |
| FLUID DISPENSING SYSTEM (K800362) | Pharmaseal Laboratories | 1980-03-12 |
| SYRINGE TIP CONNECTOR (K800437) | Burron Medical Products, Inc. | 1980-03-12 |
| MULTI-AD FLUID DISPENSING SYSTEM (K792227) | National Patent Development Corp. | 1979-12-20 |
| PINT BOTTLE WELL (K781364) | Baxa Corp., Sub. of Cook Group, Inc. | 1978-10-17 |
| STEPPER (K771539) | Tridak | 1977-10-07 |
| CUP, DISPOSABLE MEDICINE (K760517) | Landmark Plastics | 1976-11-12 |
Recalls involving this device
No recalls on record reference this clearance.