Earclear
FDA 510(k) K951596 · Arisil Medical
510(k) numberK951596
Submission
- Device name
- Earclear
- Applicant
- Arisil Medical
Brooklyn, NY, US - Received
- April 7, 1995
- Decision date
- May 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJV – Device, Inflation, Middle Ear
- Device class
- Unclassified
Other 510(k)s with product code MJV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252751 | Earflo (EF001)MJV · Traditional | Earflo, Inc. | 02/10/2026SE |
| K230502 | Ear Pressure Relief Device(Model:ER813B)MJV · Traditional | Ningbo Albert Novosino Co., Ltd. | 06/09/2023SE |
| K203754 | Eustachi Ear Pressure Relief DeviceMJV · Traditional | Exercore, LLC | 02/19/2021SE |
| K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000MJV · Traditional | Micromedics, Inc. | 03/14/2008SE |
| K920840 | OtoventMJV · Traditional | Abigo Medical AB | 10/05/1992SE |
Questions and answers
When was Earclear cleared by the FDA?
Earclear (K951596) received a 510(k) decision of Substantially Equivalent on May 24, 1995, 47 days after the submission was received.
What is the product code of K951596?
The FDA product code is MJV – Device, Inflation, Middle Ear, a Unclassified device.