Product code LRD
- Device name
- Applicator, Ent Drug
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.5220
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K984345 | AROMAPATCH | Envis, Inc. | 1999-03-19 |
| K932522 | AMSCO STERILE RECOVERIES SURGICAL PACKS | Amsco Sterile Recoveries, Inc. | 1994-09-09 |
| K942789 | MISTASSIST | The Merlin Corp. | 1994-08-12 |
| K940133 | THE EXPANDACELL EAR PACK | Denver Splint Co. | 1994-05-23 |
| K925022 | SURGICAL TRAY (STERILE) | Customed, Inc. | 1993-04-26 |
| K920842 | AEROSOL DELIVERY SYSTEMS | Hospitak, Inc. | 1992-05-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00714646000675 | Ear Wax Removal Kit | Bionix, LLC | 2024-07-11 |
| 00714646000729 | OtoClear SprayWash System, Single Use | Bionix, LLC | 2024-07-11 |
| 00714646000743 | 27245 | Bionix, LLC | 2024-07-11 |
| 00714646000750 | 27275 | Bionix, LLC | 2024-07-11 |
| 00859911004795 | Tabletop Waterpik Adapter Wands | Bionix, LLC | 2024-07-11 |
| 00859911004801 | Portable WaterPik Adapter Wands | Bionix, LLC | 2024-07-11 |
| 00714646000736 | OtoClear SprayWash System, Single Use Sample | Bionix, LLC | 2024-07-11 |
| 10859911004792 | Tabletop Waterpik Adapter Wands | Bionix, LLC | 2024-07-11 |
| 00714646001177 | SprayWash Adapter Wand | Bionix, LLC | 2023-08-09 |
| 00714646000477 | OtoClear Ear Irrigation System Wands | Bionix, LLC | 2023-07-21 |
| 10714646000474 | OtoClear Ear Irrigation System Wands | Bionix, LLC | 2023-07-21 |
| 06936189900746 | WUSH | GUANGDONG OKAY TECHNOLOGY CO.,LTD. | 2023-03-06 |
| 06936189900753 | WUSH | GUANGDONG OKAY TECHNOLOGY CO.,LTD. | 2023-03-06 |
| 00714646000965 | OtoClear® Ear Irrigation System (220V) | Bionix, LLC | 2022-10-27 |
| 00714646000972 | OtoClear® Ear Irrigation System (220V) | Bionix, LLC | 2022-10-27 |
| 00714646000989 | 27247 | Bionix, LLC | 2022-10-27 |
| 00859911004290 | OtoClear® Spray Wash Kit | Bionix, LLC | 2022-01-07 |
| 00859911004887 | OtoClear® Aquabot® Kit | Bionix, LLC | 2022-01-07 |
| 00859911004894 | OtoClear® Aquabot® Kit | Bionix, LLC | 2022-01-07 |
| 05060180256319 | EXMOOR | EXMOOR PLASTICS LIMITED | 2018-09-10 |
| 05060180251963 | EXMOOR | EXMOOR PLASTICS LIMITED | 2018-09-10 |
| 00859911004146 | Bionix Development Corporation | Bionix, LLC | 2017-01-28 |
| 00859911004153 | Bionix Development Corporation | Bionix, LLC | 2017-01-28 |