TULA Iontophoresis System with Earset
FDA 510(k) K150453 · Acclarent, Inc.
510(k) numberK150453
Submission
- Device name
- TULA Iontophoresis System with Earset
- Applicant
- Acclarent, Inc.
Rmenlo Park, CA, US - Received
- February 20, 2015
- Decision date
- May 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
Other 510(k)s with product code EGJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242041 | STOPWET iontophoresis apparatus (SW01)EGJ · Traditional | Taiwan Medical Electronics Co., Ltd. | 04/01/2025SE |
| K241267 | Hidroxa SE30EGJ · Traditional | Hidroxa Medical AB | 10/17/2024SE |
| K232020 | Iontophoresis ElectrodesEGJ · Traditional | Top-Rank Health Care Co., Ltd. | 10/16/2023SE |
| K192749 | DermadryEGJ · Traditional | Dermadry Laboratories, Inc. | 02/10/2020SE |
| K191436 | SaalioEGJ · Traditional | Saalmann Medical GmbH & Co. KG | 10/18/2019SE |
| K170835 | Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITEEGJ · Traditional | Hightech Development | 06/15/2018SE |
| K170291 | IontoDCEGJ · Traditional | Soterix Medical, Inc. | 05/01/2017SE |
| K133033 | Hidrex PSP1000EGJ · Traditional | Hidrex GmbH | 04/08/2015SE |
| K132832 | Activapatch Et Iontophoresis PatchEGJ · Traditional | Activatek, Inc. | 02/13/2014SE |
| K110636 | Tula Iontophoresis SystemEGJ · Traditional | Acclarent, Inc. | 06/16/2011SE |
More from Acclarent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | 02/19/2026SE |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation SystemPNZ · Traditional | 12/13/2023SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | 07/21/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | 07/20/2022SE |
| K201115 | Next Generation Balloon Dilation SystemLRC · Traditional | 08/27/2020SE |
| K201174 | TruDi CurettePGW · Traditional | 08/12/2020SE |
| K193453 | TruDi ProbePGW · Traditional | 03/23/2020SE |
| K190532 | TruDi NAV WirePGW · Traditional | 05/03/2019SE |
| K190525 | RELIEVA ULTIRRA Sinus Balloon CatheterLRC · Traditional | 05/03/2019SE |
| K183090 | Relieva Tract Balloon Dilation SystemQGK · Traditional | 04/19/2019SE |
Questions and answers
When was TULA Iontophoresis System with Earset cleared by the FDA?
TULA Iontophoresis System with Earset (K150453) received a 510(k) decision of Substantially Equivalent on May 20, 2015, 89 days after the submission was received.
What is the product code of K150453?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.